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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

LIXISENATIDE AVE0010

Sitagliptin

Insulin glargine HOE901

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lixisenatide

Sitagliptin - Januvia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

Proportion of patients with adverse events

Full Information

NCT ID

NCT02200991

First Posted

July 23, 2014

Last Updated

October 4, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02200991

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lixisenatide

Arm Type

Experimental

Arm Description

Arm Title

Sitagliptin - Januvia

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

LIXISENATIDE AVE0010

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Other Intervention Name(s)

Januvia

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

Insulin glargine HOE901

Other Intervention Name(s)

Lantus

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

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

Time Frame