Current partner codePEPTIDESDE
NCT02713477·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

20

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Insulin glargine HOE901

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: solution Route of administration: subcutaneous

Timeline

From registration to results.

  1. First posted

    Mar 18, 2016

  2. Study start

    Apr 2016

  3. Primary completion

    Jun 2016

  4. Study completion

    Jun 2016

  5. Results posted

    Not reported

  6. Registry updated

    Jun 16, 2020

Outcomes

What the study measures.

Primary outcomes

Measurement of plasma glucose concentrations

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

Secondary outcomes

Measurement of serum insulin concentrations

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

Measurement of serum C-peptide concentrations

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

Measurement of plasma glucagon concentrations

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

Measurement of plasma lixisenatide concentrations

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

Number of patients with hypoglycemic events

Time frame · Up to 2 weeks after each treatment

Number of patients with adverse events

Time frame · Up to 2 weeks after each treatment

Measurement of anti-lixisenatide antibodies

Time frame · 2 days (prior to first dosing and end of study visit)

Measurement of anti-insulin antibodies

Time frame · 2 days (prior to first dosing and end of study visit)

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

Japan. Showing up to 24 locations stored in the fast local snapshot.

Investigational Site Number 392001

Fukuoka, Japan

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

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