Phase 3
Completed N=451
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01617434 ↗Enrolled (actual)
451
Serious AEs
4.0%
Results posted
Oct 2014
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 — -1.30; -0.11 percentage of glycosylated haemoglobin — p=<0.0001
Summary
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26 |
-1.30; -0.11 | <0.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 |
-1.44; -0.16 | <0.0001 sig |
| SECONDARY Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26 |
-2.61; -1.02 | <0.0001 sig |
| SECONDARY Change in Body Weight From Baseline to Week 26 |
-3.54; -0.42 | <0.0001 sig |
| SECONDARY Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target) |
59.24; 14.02 | <0.0001 sig |
| SECONDARY Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target) |
42.91; 3.60 | <0.0001 sig |
| SECONDARY Number of Adverse Events (AEs) During The Randomised Treatment Period |
4918; 3737; 149; 101; 169; 101 | — |
| SECONDARY Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period |
126; 83 | — |
| SECONDARY Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
- HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
- Body mass index (BMI) 20-45 kg/m^2 (both inclusive)
Exclusion Criteria
- Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
- Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness
- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to screening
- Impaired liver or renal function
- Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
- Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
- Known or suspected abuse of alcohol or narcotics
Data sourced from ClinicalTrials.gov (NCT01617434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.