E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes failing lifestyle management and oral agents |
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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 | 10063624 |
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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 a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c below 7% at the end of the treatment period and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) <= 56 mg/dL (3.1 mmol/L)) over the treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of insulin glargine in comparison with the premixed insulin on:• Evolution of HbA1c level during the treatment period;• Percentage of patients who reach the target of HbA1c < 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a PG <= 70 mg/dL (3.9 mmol/L); • Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG <= 56 mg/dL (3.1 mmol/L);• Percentage of patients who reach the target of HbA1c < 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG <= 70 mg/dL (3.9 mmol/L);• Evolution of Fasting Plasma Glucose; • Evolution of 7-point plasma glucose profiles; • Evolution of weight; • Hypoglycemia occurrence; • Dose of insulins; • Evolution of liver function; • PRO: DTSQs and DTSQc; • Overall safety |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men or women aged over 35 years inclusively; 2. With Type 2 diabetes diagnosed for more than 1 year; 3. Insulin na�ve; 4. Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months; 5. HbA1c >= 7.0 % and <= 10.5%; 6. BMI <= 40 kg/m2; 7. Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary; 8. Willingness and ability to comply with the study protocol; 9. Signed informed consent obtained prior any study procedure |
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E.4 | Principal exclusion criteria |
1. Treatment with GLP-1 agonists in the 3 months prior to study entry; 2. Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week); 3. Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake…); 4. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method); 5. Hospitalized patient (except for routine diabetes check-up); 6. Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry; 7. History of sensitivity to the study drugs or to drugs with a similar chemical structure; 8. Impaired renal function: creatinine clearance < 60ml/min; 9. Impaired liver function (ALT, AST greater than 3 times the upper limit of normal range); 10. Severe gastro-intestinal disease; 11. Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry; 12. Likelihood of requiring treatments during the study which are not permitted; 13. Treatment with an investigational product in the 30 days prior to study entry; 14. Alcohol or drug abuse within the last 5 years 15. Night shift worker; 16. Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patient’s safety or limit the patient successful participation in the study; 17. Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and unlikehood of completing the study; 18. Patient is the Investigator or any sub-Investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy criterion will be the percentage of patients with an HbA1c <7% at the end of the treatment period, with no documented symptomatic hypoglycemia (confirmed by a PG <= 56 mg/dL) over the 24 week treatment period |
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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 | No |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |