DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Insulin glargine /lixisenatide fixed ratio combination (HOE901/AVE0010) (Drug); Insulin glargine (HOE901) (Drug); Metformin (Drug); re-usable pen-type self-injector device (Device); disposable self injector device (Device)

Phase: Phase 2

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

Summary

Primary Objective:

- The purpose of this study is to compare insulin glargine/ lixisenatide fixed ratio

combination versus insulin glargine on glycemic control over 24 weeks, as evaluated by HbA1c (glycosylated hemoglobin) reduction in type 2 diabetic patients treated with metformin Secondary Objectives:

- To compare insulin glargine/lixisenatide fixed ratio combination versus insulin

glargine over 24 weeks on:

- Glycemic control in relation to a meal as evaluated by post-prandial plasma

glucose and glucose excursions during a standardized meal test

- Percentage of patients reaching HbA1c <7% or ≤6. 5%

- 7-point Self-Monitored Plasma Glucose (SMPG) profile

- Body weight

- Insulin glargine dose

- Fasting Plasma Glucose (FPG)

- Percentage of patients requiring rescue therapy during the 24-week open label

treatment period

- To assess safety and tolerability of insulin glargine/ lixisenatide fixed ratio

combination.

Clinical Details

Official title: A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in HbA1c

Secondary outcome:

Change in 2-hour post-prandial plasma glucose (PPG) during meal test

Change in 2-hour plasma glucose excursion during meal test

Percentage of patients reaching HbA1c ≤6.5 % or <7 %

Change in 7-point SMPG profiles

Change in body weight

Insulin glargine dose

Change in FPG

Percentage of patients requiring rescue therapy during the 24-week open-label treatment period

Change in 30-minute and 1-hour PPG and plasma glucose excursion during meal test

Percentage of patients reaching HbA1c <7% at week 24 with no documented symptomatic hypoglycemia during the 24-week open label treatment period

Percentage of patients reaching HbA1c <7% with no weight gain

Detailed description: Approximately 27 weeks including a 24-week treatment period

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

- Patient with type 2 diabetes mellitus diagnosed for at least 1 year.

- Metformin treatment at a stable dose of at least 1. 5 g/day for at least 3 months

prior to screening. Exclusion criteria:

- Age < legal age of adulthood

- Screening HbA1c < 7% or > 10%

- Screening FPG > 250 mg/dL (> 13. 9 mmol/L)

- Pregnancy or lactation, women of childbearing potential with no effective

contraceptive method

- Type 1 diabetes mellitus

- Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months

prior to screening

- Use of insulin within the last 6 months

- Previous use of insulin, except for episode(s) of short-term treatment (≤ 15

consecutive days) due to intercurrent illness

- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN)

at screening

- Calcitonin ≥ 20 pg/ml (5. 9 pmol/l) at screening

- Alanine Transferase (ALT)> 3ULN at screening

- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy

- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic

conditions that predisposes to MTC (e. g multiple endocrine neoplasia syndromes)

- Uncontrolled or inadequately controlled hypertension at the time of screening with a

resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively

- Within the last 6 months prior to screening: history of heart failure requiring

hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures

- Body Mass Index (BMI) ≤ 20 or > 40 kg/m²

- Any previous treatment with lixisenatide

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

Locations and Contacts

Investigational Site Number 152401, Santiago 7980378, Chile

Investigational Site Number 152402, Santiago 8320000, Chile

Investigational Site Number 152403, Santiago 7500710, Chile

Investigational Site Number 152404, Santiago 7500347, Chile

Investigational Site Number 152405, Santiago 7500347, Chile

Investigational Site Number 203403, Novy Jicin 74101, Czech Republic

Investigational Site Number 203401, Plzen 32600, Czech Republic

Investigational Site Number 203402, Praha 2 12808, Czech Republic

Investigational Site Number 203405, Praha 8 18100, Czech Republic

Investigational Site Number 208401, København Nv 2400, Denmark

Investigational Site Number 208404, Køge 4600, Denmark

Investigational Site Number 208402, Slagelse 4200, Denmark

Investigational Site Number 208403, Svendborg 5700, Denmark

Investigational Site Number 250402, Narbonne 11018, France

Investigational Site Number 250404, Poitiers Cedex 86021, France

Investigational Site Number 250401, Vandoeuvre Les Nancy 54511, France

Investigational Site Number 276401, Dresden 01307, Germany

Investigational Site Number 276402, Ludwigshafen 67059, Germany

Investigational Site Number 276403, Oberhausen 46045, Germany

Investigational Site Number 348401, Balatonfüred 8230, Hungary

Investigational Site Number 348405, Budapest 1041, Hungary

Investigational Site Number 348406, Budapest 1212, Hungary

Investigational Site Number 348404, Debrecen 4043, Hungary

Investigational Site Number 348402, Szeged 6720, Hungary

Investigational Site Number 348403, Szeged 6722, Hungary

Investigational Site Number 440401, Kaunas LT-49456, Lithuania

Investigational Site Number 440402, Kaunas LT-51270, Lithuania

Investigational Site Number 440403, Kedainiai LT-57164, Lithuania

Investigational Site Number 440404, Klaipeda LT-92304, Lithuania

Investigational Site Number 484404, Acapulco 39670, Mexico

Investigational Site Number 484401, Cuernavaca 62250, Mexico

Investigational Site Number 484405, Durango 34270, Mexico

Investigational Site Number 484402, Guadalajara 44210, Mexico

Investigational Site Number 484403, Guadalajara 44656, Mexico

Investigational Site Number 616405, Bialystok 15-435, Poland

Investigational Site Number 616406, Gdansk 80-847, Poland

Investigational Site Number 616403, Krakow 31-548, Poland

Investigational Site Number 616407, Lodz 94-074, Poland

Investigational Site Number 616404, Pulawy 24-100, Poland

Investigational Site Number 616402, Szczecin 70-506, Poland

Investigational Site Number 616401, Warszawa 02-507, Poland

Investigational Site Number 642402, Brasov 500365, Romania

Investigational Site Number 642403, Bucuresti 020475, Romania

Investigational Site Number 642405, Iasi 700547, Romania

Investigational Site Number 642401, Oradea 410169, Romania

Investigational Site Number 642406, Targu Mures 540142, Romania

Investigational Site Number 642404, Timisoara 300133, Romania

Investigational Site Number 703402, Bratislava 85101, Slovakia

Investigational Site Number 703403, Kosice 04001, Slovakia

Investigational Site Number 703406, Kosice 04013, Slovakia

Investigational Site Number 703404, Moldava Nad Bodvou 04525, Slovakia

Investigational Site Number 703405, Nitra 94911, Slovakia

Investigational Site Number 703401, Zilina 01001, Slovakia

Investigational Site Number 752402, Skellefteå 931 32, Sweden

Investigational Site Number 752401, Stockholm 171 76, Sweden

Investigational Site Number 752403, Växjö 351 85, Sweden

Investigational Site Number 840408, Little Rock, Arkansas 72205, United States

Investigational Site Number 840412, Paramount, California 90723, United States

Investigational Site Number 840401, Larenceville, Georgia 30045, United States

Investigational Site Number 840417, Roswell, Georgia 30076, United States

Investigational Site Number 840403, Lexington, Kentucky 40504, United States

Investigational Site Number 840404, Hyattsville, Maryland 20782, United States

Investigational Site Number 840405, Rockville, Maryland 20852, United States

Investigational Site Number 840411, Las Vegas, Nevada 89148, United States

Investigational Site Number 840415, West Seneca, New York 14224, United States

Investigational Site Number 840402, Norman, Oklahoma 73069, United States

Investigational Site Number 840407, Medford, Oregon 97504, United States

Investigational Site Number 840413, Durham, Pennsylvania 27713, United States

Investigational Site Number 840410, Dallas, Texas 75230, United States

Investigational Site Number 840414, Renton, Washington 98055, United States

Additional Information

Starting date: November 2011
Last updated: January 27, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017