Current partner codePEPTIDESDE
NCT01572649·Phase 1·INTERVENTIONAL

Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

Status

Completed

Phase

Phase 1

Enrollment

24

Locations

6

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

Primary Objective: \- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls Secondary Objectives: \- To evaluate in both paediatric and adult populations: * the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses * the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast * safety and tolerability.

Full detailed description

The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose administration.

Interventions

Treatment arms and agents.

DRUG

Lixisenatide (AVE0010)

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Timeline

From registration to results.

  1. First posted

    Apr 6, 2012

  2. Study start

    May 2012

  3. Primary completion

    Mar 2014

  4. Study completion

    Mar 2014

  5. Results posted

    Not reported

  6. Registry updated

    May 23, 2014

Outcomes

What the study measures.

Primary outcomes

GLU-AUC 0:30-4:30h: area under the plasma glucose concentration time profile from time of the standardized breakfast start (30 min after IMP injection and pre-meal plasma glucose) until 4 hours later subtracting the pre-meal value

Time frame · D1 at each period up to 4h30 after study drug injection (8 timepoints)

Secondary outcomes

Pharmacokinetics: lixisenatide plasma concentration

Time frame · 0 (predose), 30 min, 1h, 1h30, 2h30, 3h30, 4h30 and 6h30 post-dose at D1 of each study period (8 timepoints)

Pharmacokinetic parameter (Cmax)

Time frame · calculated over the period of timepoints at D1 of each study period

Pharmacokinetic parameter (Tmax)

Time frame · calculated over the period of timepoints at D1 of each study period

Pharmacokinetic parameter (AUC last)

Time frame · estimated over the period of timepoints at D1 of each study period

Pharmacokinetic parameter (AUC)

Time frame · extrapolated based on the period of timepoints at D1 of each study period

Area under the concentration time profile from time of standardized breakfast start (30 min after IMP injection) until 4 hours later for insulin, C-peptide and glucagon

Time frame · D1 at each period up to 4h30 after study drug injection (7 timepoints)

Eligibility

Who can take part.

Minimum age
10 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

Inclusion criteria : * Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year (adults) and at least 3 months for paediatric population at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization) * HbA1c ≥ 7% and ≤ 10% at screening * Age eligibility for paediatric population: ≥ 10 years and \<18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: ≥ 18 and ≤ 65 years * For paediatric population:body weight \>50kg, BMI \>85th percentile for age and gender and BMI ≤ 50 kg/m² * For adults: BMI \> 25 kg/m2 and ≤ 37 kg/m2 Exclusion criteria: * If female, pregnancy (defined as positive serum pregnancy test), breast-feeding * Diabetes other than type 2 diabetes * Positive test for insulinoma associated protein (IA2) and glutamic acid decarboxylase (GAD) autoantibodies * Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening * Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) or to metacresol * History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease * Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study locations

6 registered sites.

Mexico · South Africa · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Investigational Site Number 840005

Chula Vista, California, United States

Investigational Site Number 840001

Overland Park, Kansas, United States

Investigational Site Number 840003

Louisville, Kentucky, United States

Investigational Site Number 484001

Puebla City, Mexico

Investigational Site Number 710002

Cape Town, South Africa

Investigational Site Number 826001

Leeds, United Kingdom

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Lixisenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.