Primary outcomeMean· Week 0, Week 16
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
| Group | Value (percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| Lira + Insulin | -1.73 | 0.06 |
| Placebo + Insulin | -0.43 | 0.06 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEfficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes
NCTNCT01572740 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3925Other idU1111-1122-4320Other idJapicCTI-121802
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 257 participants (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Randomized · Double masking
- Countries
1 country
Japan
- Start
- 5 Apr 2012
- Primary completion
- 1 Nov 2012
- Completion
- 27 Mar 2013
- First posted
- 6 Apr 2012 (estimated)
- Last update posted
- 7 Feb 2018
- 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
Efficacy and Safety of Liraglutide in Combination With Insulin Therapy Compared to Insulin Alone in Japanese Subjects With Type 2 Diabetes
NCT015727405 Apr 2012 to 27 Mar 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This trial is conducted in Asia. The purpose of the trial is to investigate the efficacy and safety of liraglutide in combination with insulin therapy compared to insulin alone in Japanese subjects with type 2 diabetes mellitus. Subjects will remain on their pre-trial insulin therapy.
Interventions
- liraglutideDrug
- placeboDrug
- insulinDrug
Arms2
Experimental
Lira+Insulin
Placebo comparator
Placebo+Insulin
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16
Time frame · Week 0, Week 16
Registry description
Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.
Secondary outcomes(11)
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36
Time frame · Week 0, Week 36
Registry description
Estimated mean change from baseline in HbA1c after 36 Weeks of treatment
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
Time frame · Week 0, Week 16
Registry description
Estimated mean change from baseline in FPG after 16 Weeks of treatment.
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36
Time frame · Week 0, Week 36
Registry description
Estimated mean change from baseline in FPG after 36 Weeks of treatment.
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16
Time frame · Week 0, Week 16
Registry description
Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36
Time frame · Week 0, Week 36
Registry description
Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16
Time frame · Week 0, Week 16
Registry description
Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36
Time frame · Week 0, Week 36
Registry description
Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.
Change in Body Weight From Baseline to Week 16
Time frame · Week 0, Week 16
Registry description
Estimated mean change in body weight after 16 Weeks of treatment
Change in Body Weight From Baseline to Week 36
Time frame · Week 0, Week 36
Registry description
Estimated mean change in body weight after 36 Weeks of treatment
Number of Adverse Events (AEs)
Time frame · Week 0 to Week 36 (inclusive)
Registry description
An AE was defined as treatment emergent if the onset date 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.
Number of Confirmed Hypoglycaemic Episodes
Time frame · Week 0 to week 36 (inclusive)
Registry description
A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG \< 3.1 mmol/L (56 mg/dL). Minor: PG \< 3.1 mmol/L (56 mg/dL).
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, Week 36
Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36
| Group | Value (percentage of glycosylated haemoglobin) | Spread |
|---|---|---|
| Lira + Insulin | -1.68 | 0.06 |
| Placebo + Insulin | -0.88 | 0.06 |
Secondary outcomeMean· Week 0, Week 16
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lira + Insulin | -1.31 | 0.17 |
| Placebo + Insulin | -0.48 | 0.17 |
Secondary outcomeMean· Week 0, Week 36
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lira + Insulin | -1.55 | 0.16 |
| Placebo + Insulin | -1.29 | 0.16 |
Secondary outcomeMean· Week 0, Week 16
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lira + Insulin | -2.41 | 0.18 |
| Placebo + Insulin | -0.53 | 0.18 |
Secondary outcomeMean· Week 0, Week 36
Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lira + Insulin | -2.65 | 0.16 |
| Placebo + Insulin | -1.37 | 0.16 |
Secondary outcomeMean· Week 0, Week 16
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lira + Insulin | -1.34 | 0.17 |
| Placebo + Insulin | -0.61 | 0.17 |
Secondary outcomeMean· Week 0, Week 36
Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Lira + Insulin | -1.34 | 0.21 |
| Placebo + Insulin | -0.94 | 0.21 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Lira + InsulinLiraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily \[OD\] or twice daily \[BID\], premixed: OD or BID or basal-bolus regimen \[basal: OD or BID and bolus: three times a day\]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted. | – | 6 / 127 | 93 / 127 |
| Placebo + InsulinLiraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks. All subjects continued their pre-trial insulin therapy (basal: once daily \[OD\] or twice daily \[BID\], premixed: OD or BID or basal-bolus regimen \[basal: OD or BID and bolus: three times a day\]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted. | – | 4 / 130 | 69 / 130 |
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
2 studies on this page
Indexing hint: Randomized controlled trial · 2018
4 results
Efficacy and safety of adding liraglutide to existing insulin regimens in Japanese patients with type 2 diabetes mellitus: A post-hoc analysis of a phase 3 randomized clinical trial.
Kaneko et al. 2018Journal of diabetes investigationcited by 6
PMID 29277968PMC6031509DOI 10.1111/jdi.12793PUB-29277968
Free to read · publisher termsCC BY-NC-ND4 results
Indexing hint: Randomized controlled trial · 2016
8 results
Combination therapy with liraglutide and insulin in Japanese patients with type 2 diabetes: A 36-week, randomized, double-blind, parallel-group trial.
Seino et al. 2016Journal of diabetes investigationcited by 50
PMID 27182042PMC4931207DOI 10.1111/jdi.12457PUB-27182042
Free to read · publisher termsCC BY-NC-ND8 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
* Current insulin therapy (basal insulin, premixed insulin or basal-bolus regimen) in addition to diet and exercise therapy for at least 12 weeks prior to trial start. Their therapy is stable and fluctuation of total daily insulin dose is within plus/minus 20% for at least 12 weeks prior to trial start and current total daily insulin dose equal to or greater than 10 (I)U/day
* Glycosylated haemoglobin (HbA1c) between 7.5 and 11.0% (both inclusive)
* Body Mass Index (BMI) below 45.0 kg/m\^2
Exclusion Criteria:
* Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as, but not limited to systemic corticosteroids, beta-antagonists or monoamine oxidase (MAO) inhibitors
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Known proliferative retinopathy or maculopathy requiring treatment according to the investigator
* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist within 12 weeks prior to screening
* Treatment with any oral antidiabetic drugs (OADs) within 12 weeks prior to screening
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