Clinical Trials Register

Summary
EudraCT Number:	2015-001186-46
Sponsor's Protocol Code Number:	GLARGL07699
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-07-31
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2015-001186-46

A.3

Full title of the trial

A 28-week, prospective, single-arm, open label phase 4 study to evaluate treatment optimization with once-daily insulin glargine HOE901-300 IU/ml in combination with prandial rapid-acting insulin analogue in patients with type 1 diabetes previously uncontrolled on twice daily basal insulin as part of basal-bolus therapy

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A 28-week trial to determine treatment optimization with once-daily TOUJEO in combination with prandial rapid-acting insulin analogue in patients with type 1 diabetes previously uncontrolled on twice daily basal insulin as part of basal-bolus therapy

A.3.2

Name or abbreviated title of the trial where available

OPTIMIZE

A.4.1

Sponsor's protocol code number

GLARGL07699

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	sanofi Belgium
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	sanofi-aventis Groupe
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sanofi Belgium
B.5.2	Functional name of contact point	Brigitte De Witte
B.5.3	Address:
B.5.3.1	Street Address	Airport Plaza -Montreal Building, L. Da Vincilaan 19
B.5.3.2	Town/ city	Diegem
B.5.3.3	Post code	1831
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+32 (0)2 710 54 00
B.5.5	Fax number	+32(0)2 710 56 99
B.5.6	E-mail	CTA.Belgium@sanofi.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Toujeo
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis Deutschland GmbH
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Insulin glargine
D.3.2	Product code	HOE901 - U300
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN GLARGINE
D.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	HOE901 - U300
D.3.9.4	EV Substance Code	SUB08196MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Information not present in EudraCT
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	Information not present in EudraCT
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Information not present in EudraCT
D.3.11.7	Plasma derived medicinal product	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	Information not present in EudraCT
D.3.11.11	Herbal medicinal product	Information not present in EudraCT
D.3.11.12	Homeopathic medicinal product	Information not present in EudraCT
D.3.11.13	Another type of medicinal product	Information not present in EudraCT

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Type 1 diabetes mellitus

E.1.1.1

Medical condition in easily understood language

Type 1 diabetes mellitus

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10067584
E.1.2	Term	Type 1 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of optimizing treatment from BID basal to OD insulin glargine HOE901-300 IU/mL as part of basal bolus regime in terms of improving HbA1c by at least 0.3% in uncontrolled type 1 diabetes mellitus patients.

E.2.2

Secondary objectives of the trial

• To evaluate other efficacy parameters in terms of glycemic control as well as safety including hypoglycemia events, weight changes and adverse events
• To evaluate the effect of Insulin glargine HOE901-300 IU/ml on diabetes treatment satisfaction and fear of hypoglycemia as well as patient’s satisfaction regarding the number of daily injections

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Male or Female
• Age ≥ 18 years
• With Type 1 diabetes mellitus
• Being treated BID with any basal insulin in combination with prandial rapid-acting insulin analogue for at least one year
• Have an HbA1c measurement of 8.0% – 10.0% at study entry
• Patients who have signed an Informed Consent Form

E.4

Principal exclusion criteria

• Type 2 diabetes mellitus
• Known hypoglycaemia unawareness
• Repeated episodes of severe hypoglycemia or DKA within the last 12 months
• End-stage renal failure or being on hemodialysis
• Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening or baseline, or any major systemic disease resulting in short life expectancy that in the opinion of the Investigator would restrict or limit the patient’s successful participation for the duration of the study
• Known hypersensitivity / intolerance to insulin glargine or any of its excipients
• Patients treated with GLP-1 receptor agonists
• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 90 days prior to the time of screening
• Pregnant or lactating women
• Women of childbearing potential with no effective contraceptive method
• Participation in another clinical trial
• Patient who withdraws consent during the screening or run-in phase (patient who is not willing to continue or fails to return)
• Patients who cannot demonstrate the proper use of injection pens, diary or glucose meter before receiving the first injection of Insulin glargine HOE901-300 IU/ml

E.5 End points

E.5.1

Primary end point(s)

Mean HbA1c change

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline to Week 24

E.5.2

Secondary end point(s)

• Mean HbA1c change from baseline to Week 12
• Mean change in FPG from baseline to Week 12 and Week 24
• Mean change in fasting SMBG from baseline to Week 4, Week 8, Week 12 and Week 24
• Mean change in 8-point SMBG from baseline to Week 12 and Week 24
• Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24
• Proportion of patients achieving HbA1c target of <7.0% at Week 12 and Week 24 without hypoglycemia during the last 4 weeks of treatment
• Mean change in body weight from baseline to Week 12 and Week 24
• Mean change in daily insulin doses (basal, prandial, total) from baseline to Week 24
• Proportion of patients achieving HbA1c improvement from baseline to week 24 of at least 0.3% without nocturnal hypoglycemia (documented ≤ 70 mg/dL or 3.9 mmol/L) and/or severe hypoglycemia (nocturnal defined as time between 00:00 and 05:59 am) during the last 4 weeks of treatment
• Number and proportion of patients experiencing hypoglycemia and number of hypoglycemic events per patient-year during the run-in period, the first 8 weeks of Insulin glargine HOE901-300 IU/ml treatment period, during the whole Insulin glargine HOE901-300 IU/ml treatment period, and during the last 4 weeks of the study. Hypoglycemic events will be recorded
o According to definitions (severe, confirmed ≤70mg/dL and <54mg/dL, and/or severe, confirmed ≤70mg/dL and <54mg/dL)
o And according to the time (nocturnal defined as time between 00.00 and 05:59 am, and at any time of the day)
• Proportion of patients with any improvement in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated during the 4-week run-in period and the last 4 weeks of Insulin glargine HOE901-300 IU/ml treatment period
• Proportion of patients with no deterioration in HbA1c from baseline to week 24 and decrease in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated during the 4-week run-in period and the last 4 weeks of Insulin glargine HOE901-300 IU/ml treatment period
• Proportion of patients with no deterioration in HbA1c from baseline to week 24 and no increase in occurrence of nocturnal hypoglycemia (nocturnal defined as time between 00.00 and 05:59 am) evaluated during the 4-week run-in period and the last 4 weeks of Insulin glargine HOE901-300 IU/ml treatment period
• Frequency of AEs/SAEs
• Change in DTSQs from screening to baseline, from baseline to Week 12 and 24, and from Week 12 to Week 24
• Mean change from screening to baseline, baseline to Week 12 and Week 24, and Week 12 to Week 24 on the DTSQ total treatment satisfaction, hyperglycemia perception, and hypoglycemia perception scales
• Mean change from baseline to Week 24 on the Adult Low Blood Sugar Survey (Hypoglycemia Fear Scale; HFS-II) Behavior, Worry, and Total scores
• Patient’s satisfaction with the number of injections per day, and importance for the patient of decreasing the number of basal insulin injections assessed on a 7 point Likert scale (6=very satisfied; 0=very dissatisfied)

E.5.2.1

Timepoint(s) of evaluation of this end point

From baseline to Month 6

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Prospective single-arm study

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

A 3-month extension has been foreseen to cover the gap between the end of the study of the first patients and the marketing of the product.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-08-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-05-10

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