E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes treated with metformin and not adequately controlled |
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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 |
E.1.2 | Term | Type II diabetes mellitus inadequate control |
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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 |
The primary objective of this study is to demonstrate the superiority of insulin glargine over sitagliptin in reducing HbA1c from baseline to the end of the treatment period. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to assess the effect of insulin glargine in comparison with sitagliptin on: Efficacy parameters: • HbA1c levels • Fasting Plasma Glucose • 7-point plasma glucose profiles • Percentage of patients with HbA1c <7% and <6.5%
Safety parameters: • Hypoglycemia occurrence • Body weight • Overall safety
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients aged from 35 to 70 years, inclusively, 2. With type 2 Diabetes diagnosed for at least 6 months, 3. Not previously treated with insulin, 4. On metformin for at least 3 months and: - With a stable minimal dose of 1.7 g/day for at least 2 months, - Or if metformin is poorly tolerated, with a stable minimal dose of 1 g/day for at least 2 months, 5. HbA1c ≥ 7 and < 11 %, 6. BMI between 25 and 45 kg/m2, inclusively, 7. Ability and willingness to perform plasma glucose (PG) monitoring using the Sponsor-provided PG meter and to complete the patient diary, 8. Signed informed consent obtained prior any study procedure, 9. Willingness and ability to comply with the study protocol.
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E.4 | Principal exclusion criteria |
1. Treatment with oral antidiabetic drugs other than metformin within the last 3 months, 2. Treatment with the combination of metformin + sulfonylurea for more than 1 year, 3. Previous treatment with GLP-1 agonists or DPP IV inhibitors, 4. FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L), 5. Diabetes other than type 2 diabetes, 6. Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method), 7. In-patient care, 8. 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, 9. Impaired renal function: serum creatinine ≥ 1.5 mg/dL (≥ 133 µmol/L) or ≥ 1.4 mg/dL (≥ 124 µmol/L) in men and women, respectively, 10. History of sensitivity to the study drugs or to drugs with a similar chemical structure, 11. Impaired hepatic function (ALAT, ASAT > 3 x upper limit of normal range), 12. Treatment with systemic corticosteroids within the 3 months prior to study entry or likehood of requiring treatment during the study that are not permitted during the study, 13. Alcohol or drug abuse in the last year, 14. Night shift worker 15. Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient’s 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 efficacy variable will be the change in HbA1c from baseline to study endpoint. The study endpoint is defined as the last available HbA1c value measured during the study treatment phase plus 14 days after last dose.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
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 | 8 |