Back to resultsPostprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010
Insulin glargine HOE901
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility 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.
Sites / Locations
- Investigational Site Number 392001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Other
Arm Label
Insulin glargine/ lixisenatide dose 1 Test 1
Insulin glargine/ lixisenatide dose 2 Test 2
Placebo - Reference 1
Insulin glargine (Lantus) - Reference 2
Arm Description
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
Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition
Outcomes
Primary Outcome Measures
Measurement of plasma glucose concentrations
Secondary Outcome Measures
Measurement of serum insulin concentrations
Measurement of serum C-peptide concentrations
Measurement of plasma glucagon concentrations
Measurement of plasma lixisenatide concentrations
Number of patients with hypoglycemic events
Number of patients with adverse events
Measurement of anti-lixisenatide antibodies
Measurement of anti-insulin antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02713477
Brief Title
Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
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 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin glargine/ lixisenatide dose 1 Test 1
Arm Type
Experimental
Arm Description
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
Arm Title
Insulin glargine/ lixisenatide dose 2 Test 2
Arm Type
Experimental
Arm Description
Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Arm Title
Placebo - Reference 1
Arm Type
Placebo Comparator
Arm Description
Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition
Arm Title
Insulin glargine (Lantus) - Reference 2
Arm Type
Other
Arm Description
Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition
Intervention Type
Drug
Intervention Name(s)
Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010
Intervention Description
Pharmaceutical form: solution
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Insulin glargine HOE901
Other Intervention Name(s)
Lantus
Intervention Description
Pharmaceutical form: solution
Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: solution
Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Measurement of plasma glucose concentrations
Time Frame
1 day (D1) in each treatment period
Secondary Outcome Measure Information:
Title
Measurement of serum insulin concentrations
Time Frame
1 day (D1) in each treatment period
Title
Measurement of serum C-peptide concentrations
Time Frame
1 day (D1) in each treatment period
Title
Measurement of plasma glucagon concentrations
Time Frame
1 day (D1) in each treatment period
Title
Measurement of plasma lixisenatide concentrations
Time Frame
1 day (D1) in each treatment period
Title
Number of patients with hypoglycemic events
Time Frame
Up to 2 weeks after each treatment
Title
Number of patients with adverse events
Time Frame
Up to 2 weeks after each treatment
Title
Measurement of anti-lixisenatide antibodies
Time Frame
2 days (prior to first dosing and end of study visit)
Title
Measurement of anti-insulin antibodies
Time Frame
2 days (prior to first dosing and end of study visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392001
City
Fukuoka-Shi
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31050109
Citation
Inoue M, Lorenz M, Muto H, Wesch R, Hashimoto Y. Effect of a single dose of insulin glargine/lixisenatide fixed ratio combination (iGlarLixi) on postprandial glucodynamic response in Japanese patients with type 2 diabetes mellitus: A phase I randomized trial. Diabetes Obes Metab. 2019 Aug;21(8):2001-2005. doi: 10.1111/dom.13757. Epub 2019 May 24.
Results Reference
result
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Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
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