Primary outcomeMean· Week 0 to Week 26
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
| Group | Value (percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| Liraglutide | -1.30 | 1.015 |
| Placebo | -0.11 | 1.088 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataThe Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
NCTNCT01617434 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3917Other id2011-002696-41Other idU1111-1121-9874
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 451 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Double masking
- Countries
9 countries
United States, Argentina, Canada, Finland, Germany, India, Mexico, Netherlands, Serbia
- Start
- Sept 2012
- Primary completion
- Oct 2013
- Completion
- Oct 2013
- First posted
- 12 Jun 2012 (estimated)
- Last update posted
- 8 Mar 2017
- Conditions
- Diabetes · Diabetes Mellitus, Type 2
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201220132014
- Ph 3
The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes
NCT01617434Sept 2012 to Oct 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- liraglutideDrug
- placeboDrug
Arms2
Experimental
Liraglutide
Placebo comparator
Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26
Time frame · Week 0 to Week 26
Registry description
The estimated mean change from baseline in HbA1c after 26 weeks of treatment.
Secondary outcomes(8)
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Time frame · Week 0 to Week 26
Registry description
The estimated mean change from baseline in FPG after 26 weeks of treatment.
Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26
Time frame · Week 0 to Week 26
Registry description
The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.
Change in Body Weight From Baseline to Week 26
Time frame · Week 0 to Week 26
Registry description
The estimated mean change in body weight after 26 weeks of treatment.
Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)
Time frame · At Week 26
Registry description
Number of subjects achieving HbA1c below 7.0% (American Diabetes Association \[ADA\] target) after 26 weeks of treatment
Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
Time frame · At Week 26
Registry description
Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists \[AACE\] target) after 26 weeks of treatment.
Number of Adverse Events (AEs) During The Randomised Treatment Period
Time frame · Week 0 to Week 26 + 7 days follow up
Registry description
An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.
Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period
Time frame · Week 0 to Week 26 + 7 days follow up
Registry description
A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose value \<3.1 mmol/L (56 mg/dL).
Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period
Time frame · Week 0 to Week 26 + 7 days follow up
Registry description
Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Week 0 to Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Liraglutide | -1.44 | 2.494 |
| Placebo | -0.16 | 3.006 |
Secondary outcomeMean· Week 0 to Week 26
Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Liraglutide | -2.61 | 2.248 |
| Placebo | -1.02 | 3.061 |
Secondary outcomeMean· Week 0 to Week 26
Change in Body Weight From Baseline to Week 26
| Group | Value (kg) | Spread |
|---|---|---|
| Liraglutide | -3.54 | 3.669 |
| Placebo | -0.42 | 3.909 |
Secondary outcomeNumber· At Week 26
Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)
| Group | Value (percentage of subjects) |
|---|---|
| Liraglutide | 59.24 |
| Placebo | 14.02 |
Secondary outcomeNumber· At Week 26
Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)
| Group | Value (percentage of subjects) |
|---|---|
| Liraglutide | 42.91 |
| Placebo | 3.60 |
Secondary outcomeNumber· Week 0 to Week 26 + 7 days follow up
Number of Adverse Events (AEs) During The Randomised Treatment Period
| Group | Value (Events/1000 years of patient exposure) |
|---|---|
| Liraglutide | 4918 |
| Placebo | 3737 |
Secondary outcomeNumber· Week 0 to Week 26 + 7 days follow up
Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period
| Group | Value (Events/100 years of patient exposure) |
|---|---|
| Liraglutide | 126 |
| Placebo | 83 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LiraglutideLiraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day. | – | 11 / 225 | 103 / 225 |
| PlaceboPlacebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day. | – | 7 / 225 | 46 / 225 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2015
13 results
Efficacy and safety of liraglutide versus placebo added to basal insulin analogues (with or without metformin) in patients with type 2 diabetes: a randomized, placebo-controlled trial.
Ahmann et al. 2015Diabetes, obesity & metabolismcited by 83
PMID 26179619PMC5054929DOI 10.1111/dom.12539PUB-26179619
Free to read · publisher termsCC BY-NC-ND13 results
More studies
1 study on this page
PubMed tag: none · 2015
IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy.
Freemantle et al. 2015Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 20
PMID 26582052PMC4674480DOI 10.1007/s13300-015-0142-yPUB-26582052
Free to read · publisher termsCC BY-NC
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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