Trials / Completed
CompletedNCT02713477
Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM). Secondary Objectives: * To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM. * To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM. * To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
Detailed description
The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Insulin glargine HOE901 | Pharmaceutical form: solution Route of administration: subcutaneous |
| DRUG | Placebo | Pharmaceutical form: solution Route of administration: subcutaneous |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2016-03-18
- Last updated
- 2020-06-16
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02713477. Inclusion in this directory is not an endorsement.