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

October 4, 2016 updated by: Sanofi

A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration per patient could be minimum of 38 to 47 days depending on screening visit and post-treatment observation allowances.

13C-acetic acid breath test will be conducted only in investigational site which can be implemented (about 40 patients).

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Atsugi-shi, Japan
        • Investigational Site Number 392-107
      • Chiyoda-ku, Japan
        • Investigational Site Number 392-125
      • Chuoh-ku, Japan
        • Investigational Site Number 392-121
      • Ichihara-shi, Japan
        • Investigational Site Number 392-102
      • Kawaguchi-shi, Japan
        • Investigational Site Number 392-103
      • Kitamoto-shi, Japan
        • Investigational Site Number 392-114
      • Kobe-shi, Japan
        • Investigational Site Number 392-122
      • Kumamoto-shi, Japan
        • Investigational Site Number 392-126
      • Kumamoto-shi, Japan
        • Investigational Site Number 392-127
      • Kyoto-shi, Japan
        • Investigational Site Number 392-101
      • Matsudo-shi, Japan
        • Investigational Site Number 392-106
      • Mitaka-shi, Japan
        • Investigational Site Number 392-124
      • Mito-shi, Japan
        • Investigational Site Number 392-108
      • Nerima-ku, Japan
        • Investigational Site Number 392-119
      • Okayama-shi, Japan
        • Investigational Site Number 392-117
      • Sagamihara-shi, Japan
        • Investigational Site Number 392-111
      • Sapporo-shi, Japan
        • Investigational Site Number 392-110
      • Satsumasendai-shi, Japan
        • Investigational Site Number 392-116
      • Shizuoka-shi, Japan
        • Investigational Site Number 392-105
      • Suita-shi, Japan
        • Investigational Site Number 392-118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lixisenatide

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
Pharmaceutical form:solution Route of administration: subcutaneous
Drug: Insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Other Names:
  • Lantus
Active Comparator: Sitagliptin - Januvia

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: Insulin glargine HOE901
Pharmaceutical form:solution Route of administration: subcutaneous
Other Names:
  • Lantus
Drug: Sitagliptin
Pharmaceutical form:tablet Route of administration: oral
Other Names:
  • Januvia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast
Time Frame: Day 29 after first intake of investigational product
Day 29 after first intake of investigational product

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast
Time Frame: Day 29 after first intake of investigational product
Day 29 after first intake of investigational product
Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast
Time Frame: Day 29 after first intake of investigational product
Day 29 after first intake of investigational product
Change from baseline in glucagon levels at Day 29 after a standardized breakfast
Time Frame: Day 29 after first intake of investigational product
Day 29 after first intake of investigational product
Change in gastric emptying half life (13C-acetic acid breath test)
Time Frame: Day 29 after first intake of investigational product
Day 29 after first intake of investigational product
Proportion of patients with adverse events
Time Frame: Up to Day 33 from the first intake of investigational medicinal product
Up to Day 33 from the first intake of investigational medicinal product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 24, 2014

First Posted (Estimate)

July 25, 2014

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIXISL06651
  • U1111-1159-5323 (UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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