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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02713477 (opens ClinicalTrials.gov in a new tab)Other idPDY14115Other idU1111-1176-6235
Open at ClinicalTrials.govAsk about this trial

Overview

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

Japan

Start
Apr 2016
Primary completion
Jun 2016
Completion
Jun 2016
First posted
18 Mar 2016 (estimated)
Last update posted
16 Jun 2020
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017
  1. Ph 1

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

    NCT02713477

    Apr 2016 to Jun 2016

Registry summary

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

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.

Interventions

  • Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010Drug
  • Insulin glargine HOE901Drug
  • PlaceboDrug

Arms4

  • 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

  • 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

  • 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

  • Other

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Measurement of plasma glucose concentrations

    Time frame · 1 day (D1) in each treatment period

Secondary outcomes(8)

  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)

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 · 2019

2 results

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.

Inoue et al. 2019Diabetes, obesity & metabolismcited by 9

PMID 31050109PMC6771557DOI 10.1111/dom.13757PUB-31050109

CC BY2 results
Download PDFSee results (2)

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 : * 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.

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