Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin

This study has been completed.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: June 26, 2012
Last updated: June 12, 2015
Last verified: June 2015

Primary Objective:

- To assess the effects on glycemic control of lixisenatide in comparison to placebo as an add-on treatment to basal insulin with or without metformin in terms of HbA1c reduction over a period of 24 weeks in insufficiently controlled type 2 diabetic patients.

Secondary Objectives:

  • To assess the effects of lixisenatide over 24 weeks on :

    • percentage of patients reaching HbA1c<7% or ≤6.5%,
    • 2-hour postprandial plasma glucose (PPG) and plasma glucose (PG) excursions during standardized meal challenge test,
    • fasting plasma glucose (FPG),
    • change in 7-point self-monitored plasma glucose (SMPG) profile),
    • body weight,
    • change in daily basal insulin dose.
  • To assess lixisenatide safety and tolerability.
  • To assess anti-lixisenatide antibody development.

Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Lixisenatide (AVE0010)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Treatment Period Assessing the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin With or Without Metformin

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with HbA1c <7%, =<6.5% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Change in 2-hour postprandial plasma glucose and plasma glucose excursion [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in 7-point self monitoring plasma glucose profile (average and each point) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Change in daily basal insulin dose [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Anti-lixisenatide antibody assessment [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 447
Study Start Date: October 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lixisenatide
24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Drug: Lixisenatide (AVE0010)

Pharmaceutical form:solution

Route of administration: subcutaneous injection

Placebo Comparator: Placebo
24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
Drug: Placebo

Pharmaceutical form:solution

Route of administration: subcutaneous injection

Detailed Description:
Maximum study duration of approximately 35 weeks ± 9 days (up to 2 weeks screening + 8 weeks run-in + 24 weeks double-blind treatment+ 3 days follow-up)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria :

- Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year at the time of the screening visit insufficiently controlled with basal insulin± metformin.

Exclusion criteria:

At screening:

  • Age < legal age of adulthood.
  • HbA1c<7% or >10.5%.
  • Basal insulin treatment has not been at a stable regimen for at least 3 months and at a stable dose (± 20%) of at least 15 U/day for at least 2 months prior to screening visit.
  • If metformin is given, metformin treatment has not been at a stable dose of at least 1.0 g/day for at least 3 months prior to screening visit.
  • History of hypoglycemia unawareness.
  • Body Mass Index (BMI) ≤20 kg/m².
  • Use of other oral or injectable glucose-lowering agents other than basal insulin or metformin within 3 months prior to the time of screening.

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01632163

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Investigational Site Number 156006
Beijing, China, 100088
Investigational Site Number 156002
Beijing, China, 100853
Investigational Site Number 156004
Beijing, China, 100730
Investigational Site Number 156005
Beijing, China, 100700
Investigational Site Number 156001
Beijing, China, 100029
Investigational Site Number 156033
Beijing, China, 100034
Investigational Site Number 156016
Changchun, China, 130041
Investigational Site Number 156025
Changsha, China, 410011
Investigational Site Number 156014
Chengdu, China, 610041
Investigational Site Number 156013
Chengdu, China, 610072
Investigational Site Number 156034
Dalian, China, 116027
Investigational Site Number 156035
Fuzhou, China, 354200
Investigational Site Number 156021
Guangzhou, China, 510515
Investigational Site Number 156023
Haikou, China, 570311
Investigational Site Number 156017
Harbin, China, 150001
Investigational Site Number 156029
Jinan, China, 250013
Investigational Site Number 156026
Jinan, China, 250012
Investigational Site Number 156019
Nanjing, China, 210008
Investigational Site Number 156020
Nanjing, China, 210011
Investigational Site Number 156018
Qingdao, China, 266003
Investigational Site Number 156007
Shanghai, China, 200072
Investigational Site Number 156028
Shanghai, China, 200003
Investigational Site Number 156032
Shenyang, China, 110022
Investigational Site Number 156009
Shijiazhuang, China, 050051
Investigational Site Number 156036
Siping, China, 136000
Investigational Site Number 156010
Suzhou, China, 215004
Investigational Site Number 156008
Tianjin, China, 300052
Investigational Site Number 156027
Wuhan, China, 430030
Investigational Site Number 156012
Xi'An, China, 710061
Investigational Site Number 156011
Xi'An, China, 710032
Investigational Site Number 356019
Ahmedabad, India, 380008
Investigational Site Number 356018
Aligarh, India, 202 002
Investigational Site Number 356026
Bangalore, India, 560092
Investigational Site Number 356017
Bhubaneswar, India, 751005
Investigational Site Number 356002
Hyderabad, India, 500004
Investigational Site Number 356024
Hyderabad, India, 500063
Investigational Site Number 356015
Nagpur, India, 440012
Investigational Site Number 356008
Pune, India, 411001
Investigational Site Number 356021
Secunderabad, India, 500003
Investigational Site Number 356023
Visakhapatnam, India, 530002
Korea, Republic of
Investigational Site Number 410003
Daegu, Korea, Republic of, 705-703
Investigational Site Number 410007
Goyang, Korea, Republic of, 411-706
Investigational Site Number 410005
Seoul, Korea, Republic of, 139-872
Investigational Site Number 410006
Seoul, Korea, Republic of, 130-872
Investigational Site Number 410001
Seoul, Korea, Republic of, 136-705
Investigational Site Number 410002
Wonju, Korea, Republic of, 220-701
Russian Federation
Investigational Site Number 643007
Kirov, Russian Federation, 610014
Investigational Site Number 643006
Samara, Russian Federation, 443067
Investigational Site Number 643005
St-Petersburg, Russian Federation, 195112
Investigational Site Number 643003
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643004
St-Petersburg, Russian Federation, 194354
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi Identifier: NCT01632163     History of Changes
Other Study ID Numbers: EFC12382, U1111-1124-1213
Study First Received: June 26, 2012
Last Updated: June 12, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015