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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01632163
First received: June 26, 2012
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

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 ]

Estimated Enrollment: 432
Study Start Date: October 2012
Estimated Study Completion Date: May 2015
Estimated 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)

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632163

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Hide Study Locations
Locations
China
Investigational Site Number 156001 Active, not recruiting
Beijing, China, 100029
Investigational Site Number 156002 Active, not recruiting
Beijing, China, 100853
Investigational Site Number 156004 Active, not recruiting
Beijing, China, 100730
Investigational Site Number 156005 Active, not recruiting
Beijing, China, 100700
Investigational Site Number 156006 Active, not recruiting
Beijing, China, 100088
Investigational Site Number 156033 Completed
Beijing, China, 100034
Investigational Site Number 156016 Active, not recruiting
Changchun, China, 130041
Investigational Site Number 156025 Active, not recruiting
Changsha, China, 410011
Investigational Site Number 156013 Completed
Chengdu, China, 610072
Investigational Site Number 156014 Active, not recruiting
Chengdu, China, 610041
Investigational Site Number 156034 Active, not recruiting
Dalian, China, 116027
Investigational Site Number 156035 Active, not recruiting
Fuzhou, China, 354200
Investigational Site Number 156021 Active, not recruiting
Guangzhou, China, 510515
Investigational Site Number 156023 Active, not recruiting
Haikou, China, 570311
Investigational Site Number 156017 Active, not recruiting
Harbin, China, 150001
Investigational Site Number 156026 Active, not recruiting
Jinan, China, 250012
Investigational Site Number 156029 Completed
Jinan, China, 250013
Investigational Site Number 156019 Active, not recruiting
Nanjing, China, 210008
Investigational Site Number 156020 Active, not recruiting
Nanjing, China, 210011
Investigational Site Number 156018 Active, not recruiting
Qingdao, China, 266003
Investigational Site Number 156007 Active, not recruiting
Shanghai, China, 200072
Investigational Site Number 156028 Active, not recruiting
Shanghai, China, 200003
Investigational Site Number 156032 Active, not recruiting
Shenyang, China, 110022
Investigational Site Number 156009 Active, not recruiting
Shijiazhuang, China, 050051
Investigational Site Number 156036 Active, not recruiting
Siping, China, 136000
Investigational Site Number 156010 Active, not recruiting
Suzhou, China, 215004
Investigational Site Number 156008 Active, not recruiting
Tianjin, China, 300052
Investigational Site Number 156027 Completed
Wuhan, China, 430030
Investigational Site Number 156011 Active, not recruiting
Xi'An, China, 710032
Investigational Site Number 156012 Active, not recruiting
Xi'An, China, 710061
India
Investigational Site Number 356019 Active, not recruiting
Ahmedabad, India, 380008
Investigational Site Number 356018 Active, not recruiting
Aligarh, India, 202 002
Investigational Site Number 356009 Recruiting
Bangalore, India, 560017
Investigational Site Number 356026 Active, not recruiting
Bangalore, India, 560092
Investigational Site Number 356017 Active, not recruiting
Bhubaneswar, India, 751005
Investigational Site Number 356002 Active, not recruiting
Hyderabad, India, 500004
Investigational Site Number 356024 Active, not recruiting
Hyderabad, India, 500063
Investigational Site Number 356015 Active, not recruiting
Nagpur, India, 440012
Investigational Site Number 356008 Completed
Pune, India, 411001
Investigational Site Number 356021 Active, not recruiting
Secunderabad, India, 500003
Investigational Site Number 356023 Active, not recruiting
Visakhapatnam, India, 530002
Korea, Republic of
Investigational Site Number 410003 Completed
Daegu, Korea, Republic of, 705-717
Investigational Site Number 410007 Completed
Goyang, Korea, Republic of, 411-706
Investigational Site Number 410006 Completed
Seoul, Korea, Republic of, 130-702
Investigational Site Number 410005 Completed
Seoul, Korea, Republic of, 139-872
Investigational Site Number 410001 Completed
Seoul, Korea, Republic of, 136-705
Investigational Site Number 410002 Completed
Wonju, Korea, Republic of, 220-701
Russian Federation
Investigational Site Number 643007 Completed
Kirov, Russian Federation, 610014
Investigational Site Number 643006 Completed
Samara, Russian Federation, 443067
Investigational Site Number 643003 Completed
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643004 Completed
St-Petersburg, Russian Federation, 194354
Investigational Site Number 643005 Completed
St-Petersburg, Russian Federation, 195112
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01632163     History of Changes
Other Study ID Numbers: EFC12382, U1111-1124-1213
Study First Received: June 26, 2012
Last Updated: November 13, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014