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Trial record 43 of 61 for:    Lixisenatide

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

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ClinicalTrials.gov Identifier: NCT02200991
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE July 23, 2014
First Posted Date  ICMJE July 25, 2014
Last Update Posted Date October 5, 2016
Study Start Date  ICMJE August 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast [ Time Frame: Day 29 after first intake of investigational product ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02200991 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2014)
  • 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 ]
  • 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 ]
  • Change from baseline in glucagon levels at Day 29 after a standardized breakfast [ Time Frame: 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 ]
  • Proportion of patients with adverse events [ Time Frame: Up to Day 33 from the first intake of investigational medicinal product ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: LIXISENATIDE AVE0010
    Pharmaceutical form:solution Route of administration: subcutaneous
  • Drug: Sitagliptin
    Pharmaceutical form:tablet Route of administration: oral
    Other Name: Januvia
  • Drug: Insulin glargine HOE901
    Pharmaceutical form:solution Route of administration: subcutaneous
    Other Name: Lantus
Study Arms  ICMJE
  • 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.

    Interventions:
    • Drug: LIXISENATIDE AVE0010
    • Drug: Insulin glargine HOE901
  • 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.

    Interventions:
    • Drug: Sitagliptin
    • Drug: Insulin glargine HOE901
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2016)
136
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2014)
148
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02200991
Other Study ID Numbers  ICMJE LIXISL06651
U1111-1159-5323 ( UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP