Assessment of the Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Insufficiently Controlled With Basal Insulin +/- Metformin
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| ClinicalTrials.gov Identifier: NCT01632163 |
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Recruitment Status :
Completed
First Posted : July 2, 2012
Last Update Posted : June 15, 2015
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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:
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: Lixisenatide (AVE0010) Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 447 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, 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 |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lixisenatide
24-week treatment with lixisenatide once daily on top of basal insulin with or without metformin (at least 1.0g/day)
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Drug: Lixisenatide (AVE0010)
Pharmaceutical form:solution Route of administration: subcutaneous injection |
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Placebo Comparator: Placebo
24-week treatment with placebo once daily on top of basal insulin with or without metformin (at least 1.0g/day)
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Drug: Placebo
Pharmaceutical form:solution Route of administration: subcutaneous injection |
- Change in HbA1c [ Time Frame: from baseline to week 24 ]
- Percentage of patients with HbA1c <7%, =<6.5% [ Time Frame: at week 24 ]
- Change in 2-hour postprandial plasma glucose and plasma glucose excursion [ Time Frame: from baseline to week 24 ]
- Change in fasting plasma glucose [ Time Frame: from baseline to week 24 ]
- Change in 7-point self monitoring plasma glucose profile (average and each point) [ Time Frame: from baseline to week 24 ]
- Change in body weight [ Time Frame: from baseline to week 24 ]
- Change in daily basal insulin dose [ Time Frame: from baseline to week 24 ]
- Number of patients with adverse events [ Time Frame: 24 weeks ]
- Anti-lixisenatide antibody assessment [ Time Frame: from baseline to week 24 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632163
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| Study Director: | Clinical Sciences & Operations | Sanofi |
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01632163 |
| Other Study ID Numbers: |
EFC12382 U1111-1124-1213 ( Other Identifier: UTN ) |
| First Posted: | July 2, 2012 Key Record Dates |
| Last Update Posted: | June 15, 2015 |
| Last Verified: | June 2015 |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Lixisenatide Hypoglycemic Agents Physiological Effects of Drugs |