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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713477
• Other study ID #: PDY14115
• Secondary ID: U1111-1176-6235
• Status: Completed
• Phase: Phase 1
• Start date: April 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion criteria :

• Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history.

• Patients aged 20 to 75 years at screening.

• Body mass index =35 kg/m^2 at screening.

• Glycohemoglobin =7.0% and =10.0% at screening.

• Fasting C-peptide =0.6 ng/mL at screening.

Exclusion criteria:

• Diabetes other than T2DM.

• History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.

• History of hypoglycemia unawareness.

• Hemoglobinopathy or hemolytic anemia.

• History of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period.

• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.

• Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment.

• Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).

• If female, pregnancy or breast-feeding.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010
Pharmaceutical form: solution Route of administration: subcutaneous
• Insulin glargine HOE901
Pharmaceutical form: solution Route of administration: subcutaneous
• Placebo
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Japan	Investigational Site Number 392001	Fukuoka-Shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Inoue M, Lorenz M, Muto H, Wesch R, Hashimoto Y. Effect of a single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase I randomized tr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of plasma glucose concentrations		1 day (D1) in each treatment period
Secondary	Measurement of serum insulin concentrations		1 day (D1) in each treatment period
Secondary	Measurement of serum C-peptide concentrations		1 day (D1) in each treatment period
Secondary	Measurement of plasma glucagon concentrations		1 day (D1) in each treatment period
Secondary	Measurement of plasma lixisenatide concentrations		1 day (D1) in each treatment period
Secondary	Number of patients with hypoglycemic events		Up to 2 weeks after each treatment
Secondary	Number of patients with adverse events		Up to 2 weeks after each treatment
Secondary	Measurement of anti-lixisenatide antibodies		2 days (prior to first dosing and end of study visit)
Secondary	Measurement of anti-insulin antibodies		2 days (prior to first dosing and end of study visit)