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

NCT02713477 | Completed Phase 1

• 2 other identifiers: PDY14115U1111-1176-6235
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Measurement of plasma glucose concentrations

  1 day (D1) in each treatment period

Secondary Outcomes (8)

• 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

Study Arms (4)

Insulin glargine/ lixisenatide dose 1 Test 1

EXPERIMENTAL

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

Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

Insulin glargine/ lixisenatide dose 2 Test 2

EXPERIMENTAL

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

Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

Placebo - Reference 1

PLACEBO COMPARATOR

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

Drug: Placebo

Insulin glargine (Lantus) - Reference 2

OTHER

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

Drug: Insulin glargine HOE901

Interventions

Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Insulin glargine/ lixisenatide dose 1 Test 1; Insulin glargine/ lixisenatide dose 2 Test 2

Insulin glargine HOE901 DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: Lantus

Insulin glargine (Lantus) - Reference 2

Placebo DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Placebo - Reference 1

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Investigational Site Number 392001

Fukuoka, Japan

Location

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

  PMID: 31050109 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; lixisenatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 16, 2020

Record last verified: 2016-06

Locations

JP (1)