E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | 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 |
Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone alone on HbA1c.
Objective: To assess the safety and tolerability of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. |
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E.2.2 | Secondary objectives of the trial |
In patients with T2DM with inadequate glycemic control: Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on the 2-hour post prandial glucose (PPG) following a standard meal challenge.
Objective: After 24 weeks, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on FPG.
Objective: After 1 week, to assess the effect of the coadministration of sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. compared to pioglitazone 30 mg q.d. alone on FPG. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient has T2DM. 2. Patient is a male or female and ≥18 years of age on day of signing informed consent. 3. Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and post-study follow-up period. 4. Patient is a male, or is a female who is highly unlikely to conceive, as indicated by at least one “yes” answer to the following questions: a. Patient is a male. b. Patient is a surgically sterilized female. c. Patient is a postmenopausal female ≥45 years of age with >2 years since last menses. d. Patient is a non-sterilized premenopausal female and (if sexually active) agrees to use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method) and for 14 days after the last dose of study medication.Note: Acceptable methods of birth control are: hormonal contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy. 5. Patient understands the study procedures and agrees to participate in the study by giving written informed consent. Glycemic Entry Criteria 6. Patient has not been on any oral antihyperglycemic medication or insulin therapy prior to screening (except as described below and in Section 2.3) and has a Visit 1/ Screening Visit 1 HbA1c ≥8.0% and ≤12.0%. Note: Patients may participate who have < 4 weeks cumulative AHA therapy over the past 2 years, and with no AHA treatment over the prior 4 months. |
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E.4 | Principal exclusion criteria |
Glucose Metabolism and Therapy Criteria 1. Patient has a history of type 1 diabetes mellitus or history of ketoacidosis. 2. Patient was on antihyperglycemic agent therapy (oral or insulin) within 4 months prior to screening. 3. Patient was on > 4 weeks (cumulatively) of antihyperglycemic therapy over the prior 2 years. 4. Patient has symptomatic hyperglycemia which the investigator assesses as requiring immediate initiation of antihyperglycemic therapy (i.e., without 2 week diet and exercise run-in period). Patients Requiring Specific Treatments 5. Patient is on a weight loss program and is not in the maintenance phase or has started on a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |