Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Insulin glargine HOE901; Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

• Registration Number: NCT02713477
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-18
• Study Start: 2016-04
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo - Reference 1	Placebo	Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Insulin glargine (Lantus) - Reference 2	Insulin glargine HOE901	Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition
Insulin glargine/ lixisenatide dose 2 Test 2	Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010	Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Insulin glargine/ lixisenatide dose 1 Test 1	Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010	Test 1 will be administered thru subcutaneous (SC) injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition

Primary Outcome Measures

Name	Time	Method
Measurement of plasma glucose concentrations	1 day (D1) in each treatment period

Secondary Outcome Measures

Name	Time	Method
Measurement of serum insulin concentrations	1 day (D1) in each treatment period
Measurement of serum C-peptide concentrations	1 day (D1) in each treatment period
Measurement of plasma glucagon concentrations	1 day (D1) in each treatment period
Measurement of plasma lixisenatide concentrations	1 day (D1) in each treatment period
Number of patients with hypoglycemic events	Up to 2 weeks after each treatment
Number of patients with adverse events	Up to 2 weeks after each treatment
Measurement of anti-lixisenatide antibodies	2 days (prior to first dosing and end of study visit)
Measurement of anti-insulin antibodies	2 days (prior to first dosing and end of study visit)

Trial Locations

Locations (1)

Investigational Site Number 392001; 🇯🇵 Fukuoka-Shi, Japan