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Trial record 32 of 61 for:    Lixisenatide

Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02713477
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : June 29, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes mellitus (T2DM).

Secondary Objectives:

  • To assess the pharmacokinetics (PK) of lixisenatide following administration of 2 different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.
  • To assess the postprandial glucodynamic response to insulin glargine/lixisenatide fixed-ratio combination compared to insulin glargine alone in Japanese patients with T2DM.
  • To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio combination in Japanese patients with T2DM.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 Drug: Insulin glargine HOE901 Drug: Placebo Phase 1

Detailed Description:
The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
Study Start Date : April 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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Arm Intervention/treatment
Experimental: Insulin glargine/ lixisenatide dose 1 Test 1
Test 1 will be administered thru subcutaneous (SC) injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

Pharmaceutical form: solution

Route of administration: subcutaneous


Experimental: Insulin glargine/ lixisenatide dose 2 Test 2
Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Drug: Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

Pharmaceutical form: solution

Route of administration: subcutaneous


Placebo Comparator: Placebo - Reference 1
Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Drug: Placebo

Pharmaceutical form: solution

Route of administration: subcutaneous


Insulin glargine (Lantus) - Reference 2
Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition
Drug: Insulin glargine HOE901

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Lantus




Primary Outcome Measures :
  1. Measurement of plasma glucose concentrations [ Time Frame: 1 day (D1) in each treatment period ]

Secondary Outcome Measures :
  1. Measurement of serum insulin concentrations [ Time Frame: 1 day (D1) in each treatment period ]
  2. Measurement of serum C-peptide concentrations [ Time Frame: 1 day (D1) in each treatment period ]
  3. Measurement of plasma glucagon concentrations [ Time Frame: 1 day (D1) in each treatment period ]
  4. Measurement of plasma lixisenatide concentrations [ Time Frame: 1 day (D1) in each treatment period ]
  5. Number of patients with hypoglycemic events [ Time Frame: Up to 2 weeks after each treatment ]
  6. Number of patients with adverse events [ Time Frame: Up to 2 weeks after each treatment ]
  7. Measurement of anti-lixisenatide antibodies [ Time Frame: 2 days (prior to first dosing and end of study visit) ]
  8. Measurement of anti-insulin antibodies [ Time Frame: 2 days (prior to first dosing and end of study visit) ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history.
  • Patients aged 20 to 75 years at screening.
  • Body mass index ≤35 kg/m^2 at screening.
  • Glycohemoglobin ≥7.0% and ≤10.0% at screening.
  • Fasting C-peptide ≥0.6 ng/mL at screening.

Exclusion criteria:

  • Diabetes other than T2DM.
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
  • History of hypoglycemia unawareness.
  • Hemoglobinopathy or hemolytic anemia.
  • History of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period.
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment.
  • Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).
  • If female, pregnancy or breast-feeding.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713477


Locations
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Japan
Investigational Site Number 392001
Fukuoka-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02713477     History of Changes
Other Study ID Numbers: PDY14115
U1111-1176-6235 ( Other Identifier: UTN )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs