E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes mellitus (T2DM) insulin-naïve diagnosed by at least one year and in treatment with at least one oral hypoglycaemic at a dose stable for at least 3 months: monotherapy or combination must include metformin (daily dose of at least 1700 mg) unless it is just tolerated or contraindicated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049746 |
E.1.2 | Term | Insulin-requiring type II diabetes mellitus |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the superiority of insulin glargine over insulin NPH on the change in HbA1c from baseline to the end of the treatment period. |
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E.2.2 | Secondary objectives of the trial |
To compare between treatment groups: - Plasma glucose (fasting, nocturnal) over time, - Changes from baseline in HbA1c over time, - Percentage of patients who reach the target of HbA1c <7% and <6.5%, - Use of prandial insulin as rescue medication at month 6, - Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe), - Daily dose of insulin, - Change in body weight from baseline, - Evolution of 8-point plasma-glucose (PG) profiles, - Overall safety, - Patient reported outcomes (treatment satisfaction). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
 Aged from 30 to 70 years inclusively  Insulin-naïve type 2 diabetes mellitus (T2DM)  T2DM diagnosed for at least 1 year  Treated with at least one OAD at stable dose for at least 3 months: monotherapy or combination must include metformin (daily dose 1700 mg) unless being contra-indicated or poorly tolerated  HbA1c 7.0% and <9.0%  BMI < 40 kg/m2  Ability and willingness to perform plasma glucose monitoring Sponsor-provided glucose meter and patient diary at home  Informed consent obtained in writing at enrolment into the study  Willingness and ability to comply with the study protocol |
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E.4 | Principal exclusion criteria |
 Treatment with GLP-1 agonists in the 3 months prior to study entry  Treatment with DPP-IV inhibitors in the 3 months prior to study entry  Diabetes mellitus other than Type 2  Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)  Impaired renal function: serum creatinine ≥1.5 mg/dL (≥133µmol/L) or ≥1.4 mg/dL (≥124 µmol/L) in men and women, respectively  History of sensitivity to the study drugs or to drugs with a similar chemical structure  Impaired hepatic function (ALT and/or AST > 3 x upper limit of normal range)  Pregnancy or breastfeeding  Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.  Treatment with an investigational product in the 30 days prior to visit 1  Alcohol or drug abuse in the last year  Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patients safety or limit the patient successful participation in the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be the change in HbA1c from baseline to end of study treatment in the intent-to-treat (ITT) population. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
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 | Information not present in EudraCT |
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 |
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E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |