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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT02200991 (opens ClinicalTrials.gov in a new tab)Other idLIXISL06651Other idU1111-1159-5323
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
136 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Japan

Start
Aug 2014
Primary completion
Nov 2015
Completion
Nov 2015
First posted
25 Jul 2014 (estimated)
Last update posted
5 Oct 2016 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 4

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

    NCT02200991

    Aug 2014 to Nov 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • LIXISENATIDE AVE0010Drug
  • SitagliptinDrug
  • Insulin glargine HOE901Drug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Day 29 after first intake of investigational product

Secondary outcomes(5)

  1. 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

  2. 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

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

    Time frame · Day 29 after first intake of investigational product

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

    Time frame · Day 29 after first intake of investigational product

  5. Proportion of patients with adverse events

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

6 results

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).

Yamada et al. 2017Diabetes, obesity & metabolismcited by 6

PMID 28345162PMC5573929DOI 10.1111/dom.12945PUB-28345162

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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