Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

NCT02200991 | Completed Phase 4

• 2 other identifiers: LIXISL06651U1111-1159-5323
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 20

Brief Summary

Primary Objective: To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a standardized breakfast from baseline to Day 29. Secondary Objectives: To demonstrate:

• Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion, C-peptide and glucagon levels after a standardized breakfast
• Delaying gastric emptying (13C-acetic acid breath test)
• Safety and tolerability

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast

  Day 29 after first intake of investigational product

Secondary Outcomes (5)

• Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast

  Day 29 after first intake of investigational product

• Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast

  Day 29 after first intake of investigational product

• Change from baseline in glucagon levels at Day 29 after a standardized breakfast

  Day 29 after first intake of investigational product

• Change in gastric emptying half life (13C-acetic acid breath test)

  Day 29 after first intake of investigational product

• Proportion of patients with adverse events

  Up to Day 33 from the first intake of investigational medicinal product

Study Arms (2)

Lixisenatide

EXPERIMENTAL

Lyxumia solostar: Initially started with 10 μg once-daily and increased up to 20 μg once daily (dose increased by 5 μg every week), subcutaneous injection in the abdomen, administered 30 minutes before breakfast. The period of administration is 4 weeks. Lantus solostar as base treatment: Subcutaneous injection in the abdomen.

Drug: LIXISENATIDE AVE0010; Drug: Insulin glargine HOE901

Sitagliptin - Januvia

ACTIVE COMPARATOR

50 mg tablet, administered orally once-daily, 30 minutes before breakfast. The period of administration is 4 weeks. Lantus solostar as base treatment: Subcutaneous injection in the abdomen.

Drug: Sitagliptin; Drug: Insulin glargine HOE901

Interventions

LIXISENATIDE AVE0010 DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Lixisenatide

Sitagliptin DRUG

Pharmaceutical form:tablet Route of administration: oral

Also known as: Januvia

Sitagliptin - Januvia

Insulin glargine HOE901 DRUG

Pharmaceutical form:solution Route of administration: subcutaneous

Also known as: Lantus

Lixisenatide; Sitagliptin - Januvia

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis
• Aged 20-75 years
• Hemoglobin A1C ≥7.0%-≤10.0%
• Fasting plasma glucose ≤180 mg/dL at screening
• Stable treatment (±20%) with Lantus for 3 months or more prior to screening.
• Sulfonylurea dose stable for 3 months or more prior to screening

You may not qualify if:

• Type 1 diabetes mellitus
• Pregnancy or lactation
• Hypersensitivity to Lixisenatide
• Severely uncontrolled glycemic situation
• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease
• History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening
• History within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse
• Uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg
• Amylase and/or lipase \>3 times or aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) \>2 times the upper limit of the normal laboratory range
• End-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease
• 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 (20)

Investigational Site Number 392-107

Atsugi-shi, Japan

Location

Investigational Site Number 392-125

Chiyoda-ku, Japan

Location

Investigational Site Number 392-121

Chuoh-ku, Japan

Location

Investigational Site Number 392-102

Ichihara-shi, Japan

Location

Investigational Site Number 392-103

Kawaguchi-shi, Japan

Location

Investigational Site Number 392-114

Kitamoto-shi, Japan

Location

Investigational Site Number 392-122

Kobe, Japan

Location

Investigational Site Number 392-126

Kumamoto, Japan

Location

Investigational Site Number 392-127

Kumamoto, Japan

Location

Investigational Site Number 392-101

Kyoto, Japan

Location

Investigational Site Number 392-106

Matsudo-shi, Japan

Location

Investigational Site Number 392-124

Mitaka-shi, Japan

Location

Investigational Site Number 392-108

Mito, Japan

Location

Investigational Site Number 392-119

Nerima-ku, Japan

Location

Investigational Site Number 392-117

Okayama, Japan

Location

Investigational Site Number 392-111

Sagamihara-shi, Japan

Location

Investigational Site Number 392-110

Sapporo, Japan

Location

Investigational Site Number 392-116

Satsumasendai-shi, Japan

Location

Investigational Site Number 392-105

Shizuoka, Japan

Location

Investigational Site Number 392-118

Suita-shi, Japan

Location

Related Publications (1)

• Yamada Y, Senda M, Naito Y, Tamura M, Watanabe D, Shuto Y, Urita Y. Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study). Diabetes Obes Metab. 2017 Sep;19(9):1252-1259. doi: 10.1111/dom.12945. Epub 2017 Apr 27.

  PMID: 28345162 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

lixisenatide; Sitagliptin Phosphate; Insulin Glargine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; 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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 25, 2014
• Study Start: August 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 5, 2016

Record last verified: 2016-10

Locations

JP (20)