Trial · NCT02963922
Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
NCT02963922, Phase 3, Completed, Novo Nordisk A/S; results first posted 2019-11-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin. Trials, record NCT02963922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02963922
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect and Safety of Liraglutide 3.0 mg in Subjects With Overweight or Obesity and Type 2 Diabetes Mellitus Treated With Basal Insulin
- NCT number
- NCT02963922
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 396 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Metabolism and Nutrition Disorder, Obesity
- Interventions
- Liraglutide 3.0 mg, Placebo
- First posted
- 2016-11-15
- Last updated
- 2020-03-30
- Other registries' IDs
- eudract:2015-005619-33
- Results first posted
- 2019-11-27
Source ClinicalTrials.gov
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Weight (%) | Week 0, week 56 | Change in body weight from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Primary | Participants Losing at Least 5% of Baseline Body Weight | Week 56 | The estimated percentage of participants losing at least 5% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Secondary | Participants Losing More Than 10% of Baseline Body Weight at Week 56 | Week 56 | The estimated percentage of participants losing more than 10% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events \[AEs\]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Secondary | Change in Waist Circumference | Week 0, week 56 | Change in waist circumference from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Secondary | Change in HbA1c | Week 0, week 56 | Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Secondary | Change in FPG | Week 0, week 56 | Change in fasting plasma glucose (FPG) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Secondary | Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score | Week 0, week 56 | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) in SF-36 physical functioning score was presented based on in-trial data and on-drug data. A positive change score indicates an improvement since baseline. |
| Secondary | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score | Week 0, week 56 | Change in IWQoL-Lite for CT physical function domain (5-items) score. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. The endpoint was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). |
| Secondary | Change in Total Daily Insulin Dose (U) | Week 0, week 56 | Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
| Secondary | Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U) | Week 0, week 56 | Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 registered outcomesOutcomes46
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Body Weight (%) | Week 0, week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Percentage change | MEAN |
| PRIMARY | Participants Losing at Least 5% of Baseline Body Weight | Week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Participants Losing More Than 10% of Baseline Body Weight at Week 56 | Week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Change in Waist Circumference | Week 0, week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Centimeters (cm) | MEAN |
| SECONDARY | Change in HbA1c | Week 0, week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Percentage of HbA1c | MEAN |
| SECONDARY | Change in FPG | Week 0, week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score | Week 0, week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Score on a scale | MEAN |
| SECONDARY | Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score | Week 0, week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Score on a scale | MEAN |
| SECONDARY | Change in Total Daily Insulin Dose (U) | Week 0, week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Units of insulin dose (U) | MEAN |
| SECONDARY | Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U) | Week 0, week 56 | Full analysis set included all randomised participants. Number analyzed=participants with available data. | Percentage change | MEAN |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 outcomesResults by group492
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Body Weight (%) | Liraglutide 3.0 mg | In-trial observation period | -6.0 | Standard Deviation 6.0 | Percentage change |
| Change in Body Weight (%) | Placebo | In-trial observation period | -1.5 | Standard Deviation 5.4 | Percentage change |
| Change in Body Weight (%) | Liraglutide 3.0 mg | On-drug observation period | -6.5 | Standard Deviation 5.8 | Percentage change |
| Change in Body Weight (%) | Placebo | On-drug observation period | -1.7 | Standard Deviation 5.2 | Percentage change |
| Participants Losing at Least 5% of Baseline Body Weight | Liraglutide 3.0 mg | In-trial observation period | 51.80 | Percentage of participants | |
| Participants Losing at Least 5% of Baseline Body Weight | Placebo | In-trial observation period | 23.98 | Percentage of participants | |
| Participants Losing at Least 5% of Baseline Body Weight | Liraglutide 3.0 mg | On-drug observation period | 56.92 | Percentage of participants | |
| Participants Losing at Least 5% of Baseline Body Weight | Placebo | On-drug observation period | 21.83 | Percentage of participants | |
| Participants Losing More Than 10% of Baseline Body Weight at Week 56 | Liraglutide 3.0 mg | In-trial observation period | 22.77 | Percentage of participants | |
| Participants Losing More Than 10% of Baseline Body Weight at Week 56 | Placebo | In-trial observation period | 6.55 | Percentage of participants |
1 to 10 of 492Source ClinicalTrials.gov
See all 492 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Liraglutide 3.0 mg | 198 | |
| Overall Study | STARTED | Placebo | 198 | |
| Overall Study | COMPLETED | Liraglutide 3.0 mg | 166 | |
| Overall Study | COMPLETED | Placebo | 168 | |
| Overall Study | NOT COMPLETED | Liraglutide 3.0 mg | 32 | |
| Overall Study | NOT COMPLETED | Placebo | 30 |
Source ClinicalTrials.gov
Adverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Liraglutide 3.0 mg | 11 | 195 | 17 |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 8 | 197 | 11 |
| other | Abdominal pain upper | Gastrointestinal disorders | Liraglutide 3.0 mg | 12 | 195 | 17 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 8 | 197 | 9 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Liraglutide 3.0 mg | 12 | 195 | 14 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 24 | 197 | 37 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Liraglutide 3.0 mg | 13 | 195 | 13 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 12 | 197 | 17 |
| other | Constipation | Gastrointestinal disorders | Liraglutide 3.0 mg | 28 | 195 | 36 |
| other | Constipation | Gastrointestinal disorders | Placebo | 17 | 197 | 21 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liraglutide 3.0 mg | 0 | 195 |
| Total, all-cause mortality | Placebo | 0 | 197 |
| Total, other adverse events | Liraglutide 3.0 mg | 162 | 195 |
| Total, other adverse events | Placebo | 141 | 197 |
| Total, serious adverse events | Liraglutide 3.0 mg | 16 | 195 |
| Total, serious adverse events | Placebo | 19 | 197 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32139381 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Liraglutide 3.0 mg vs Placebo: deaths from any cause | Trial comparisons |
| Liraglutide 3.0 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02963922
GET https://conductscience.org/api/trials/v1/NCT02963922/registered?page=2