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

NCT ID: NCT02713477

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-06-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin glargine/ lixisenatide dose 1 Test 1

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

Group Type: EXPERIMENTAL

Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Insulin glargine/ lixisenatide dose 2 Test 2

Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition

Group Type: EXPERIMENTAL

Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Placebo - Reference 1

Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Insulin glargine (Lantus) - Reference 2

Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition

Group Type: OTHER

Insulin glargine HOE901

Intervention Type: DRUG

Pharmaceutical form: solution

Route of administration: subcutaneous

Interventions

Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Insulin glargine HOE901

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Placebo

Pharmaceutical form: solution

Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Lantus

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392001

Fukuoka, , Japan

Countries

Japan

References

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 trial. Diabetes Obes Metab. 2019 Aug;21(8):2001-2005. doi: 10.1111/dom.13757. Epub 2019 May 24.

Reference Type: RESULT

PMID: 31050109 (View on PubMed)

Other Identifiers

U1111-1176-6235

Identifier Type: OTHER

Identifier Source: secondary_id

PDY14115

Identifier Type: -

Identifier Source: org_study_id