Trial · NCT02730377
Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes
NCT02730377, Phase 4, Completed, Novo Nordisk A/S; results first posted 2020-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes. Trials, record NCT02730377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02730377
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes
- NCT number
- NCT02730377
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,991 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Interventions
- liraglutide, alpha-glucosidase inhibitors, DPP-4 inhibitors, meglitinides, SGLT-2 inhibitors, sulphonylurea, thiazolidinediones
- First posted
- 2016-04-06
- Last updated
- 2020-07-07
- Other registries' IDs
- eudract:2015-002417-29
- Results first posted
- 2020-07-07
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Inadequate Glycaemic Control | Weeks 26-104 | Inadequate glycaemic control was defined as glycosylated haemoglobin (HbA1c) of 7.0% (53 mmol/mol) or greater at two consecutive visits after the first 26 weeks of treatment and up to 104 weeks. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. HbA1c was recorded at weeks 38, 52, 65, 78, 91 and 104. |
| Secondary | Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) | Weeks 0-104 | The time to premature treatment discontinuation (for any reason including inadequate glycaemic control) was analysed and presented using the generalised log rank test. 25%, median (50%) and 75% percentiles for the cumulative distribution function, are obtained from the Kaplan-Meier survival function. |
| Secondary | Change in HbA1c | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in HbA1c at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Participants Who Achieve HbA1c ≤6.5% (Yes/No) | Week 104/Premature treatment discontinuation | Participants who achieved HbA1c ≤6.5% (yes/no) is presented. |
| Secondary | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain | Week 104/Premature treatment discontinuation | Participants who achieved HbA1c ≤7.0% without weight gain (yes/no) is presented. |
| Secondary | Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 104/Premature treatment discontinuation | Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \<3.1 millimoles per liter (mmol/L) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented. |
| Secondary | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | Week 104/Premature treatment discontinuation | Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than the day after the last day on trial product. Participants who achieved HbA1c ≤7.0% without weight gain and no treatment emergent severe hypoglycaemic episodes or BG confirmed symptomatic hypoglycaemic episodes (yes/no) is presented. |
| Secondary | Change in Fasting Plasma Glucose (FPG) | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in FPG at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Change in Body Weight | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in body weight at week 104 or at premature treatment discontinuation is presented. |
| Secondary | Change in Body Mass Index (BMI) | Week 0, week 104/premature treatment discontinuation | Change from baseline (week 0) in BMI at week 104 or at premature treatment discontinuation is presented. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Inadequate Glycaemic Control | Weeks 26-104 | FAS included all randomised participants. Overall number of participants analyzed=participants with available data. | Weeks | MEDIAN |
| SECONDARY | Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) | Weeks 0-104 | FAS included all randomised participants. Overall number of participants analyzed=participants with available data. | Weeks | MEDIAN |
| SECONDARY | Change in HbA1c | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Percentage point of HbA1c | MEAN |
| SECONDARY | Participants Who Achieve HbA1c ≤6.5% (Yes/No) | Week 104/Premature treatment discontinuation | FAS included all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain | Week 104/Premature treatment discontinuation | FAS included all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 104/Premature treatment discontinuation | FAS included all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | Week 104/Premature treatment discontinuation | FAS included all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change in Body Weight | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Kilogram (Kg) | MEAN |
| SECONDARY | Change in Body Mass Index (BMI) | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Kilograms per square meter (kg/m^2) | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Inadequate Glycaemic Control | Liraglutide 1.8 mg | 108.9 | Inter-Quartile Range 37.7 to NA | Weeks | |
| Time to Inadequate Glycaemic Control | Oral Antidiabetic Drug | 64.9 | Inter-Quartile Range 35.4 to 107.4 | Weeks | |
| Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) | Liraglutide 1.8 mg | 80.4 | Inter-Quartile Range 35.7 to NA | Weeks | |
| Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) | Oral Antidiabetic Drug | 52.3 | Inter-Quartile Range 35.1 to NA | Weeks | |
| Change in HbA1c | Liraglutide 1.8 mg | Change at week 104 | -1.4 | Standard Deviation 1.06 | Percentage point of HbA1c |
| Change in HbA1c | Oral Antidiabetic Drug | Change at week 104 | -1.1 | Standard Deviation 1.04 | Percentage point of HbA1c |
| Change in HbA1c | Liraglutide 1.8 mg | Change at premature treatment discontinuation | -0.6 | Standard Deviation 1.03 | Percentage point of HbA1c |
| Change in HbA1c | Oral Antidiabetic Drug | Change at premature treatment discontinuation | -0.2 | Standard Deviation 1.56 | Percentage point of HbA1c |
| Participants Who Achieve HbA1c ≤6.5% (Yes/No) | Liraglutide 1.8 mg | Yes | 255 | Participants | |
| Participants Who Achieve HbA1c ≤6.5% (Yes/No) | Oral Antidiabetic Drug | Yes | 162 | Participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Liraglutide 1.8 mg | 996 | |
| Overall Study | STARTED | Oral Antidiabetic Drug | 995 | |
| Overall Study | Treated | Liraglutide 1.8 mg | 980 | |
| Overall Study | Treated | Oral Antidiabetic Drug | 984 | |
| Overall Study | Full Analysis Set (FAS) | Liraglutide 1.8 mg | 996 | |
| Overall Study | Full Analysis Set (FAS) | Oral Antidiabetic Drug | 995 | |
| Overall Study | Safety Analysis Set (SAS) | Liraglutide 1.8 mg | 980 | |
| Overall Study | Safety Analysis Set (SAS) | Oral Antidiabetic Drug | 984 | |
| Overall Study | COMPLETED | Liraglutide 1.8 mg | 446 | |
| Overall Study | COMPLETED | Oral Antidiabetic Drug | 362 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events362
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 | Nausea | Gastrointestinal disorders | Liraglutide 1.8 mg | 65 | 980 | 82 |
| other | Nausea | Gastrointestinal disorders | Oral Antidiabetic Drug | 15 | 984 | 21 |
| serious | Abdominal pain lower | Gastrointestinal disorders | Liraglutide 1.8 mg | 0 | 980 | 0 |
| serious | Abdominal pain lower | Gastrointestinal disorders | Oral Antidiabetic Drug | 1 | 984 | 1 |
| serious | Acute kidney injury | Renal and urinary disorders | Liraglutide 1.8 mg | 6 | 980 | 7 |
| serious | Acute kidney injury | Renal and urinary disorders | Oral Antidiabetic Drug | 2 | 984 | 2 |
| serious | Acute myocardial infarction | Cardiac disorders | Liraglutide 1.8 mg | 5 | 980 | 5 |
| serious | Acute myocardial infarction | Cardiac disorders | Oral Antidiabetic Drug | 6 | 984 | 6 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Liraglutide 1.8 mg | 1 | 980 | 1 |
| serious | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Oral Antidiabetic Drug | 0 | 984 | 0 |
1 to 10 of 362Source ClinicalTrials.gov
See all 362 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liraglutide 1.8 mg | 1 | 980 |
| Total, all-cause mortality | Oral Antidiabetic Drug | 8 | 984 |
| Total, other adverse events | Liraglutide 1.8 mg | 65 | 980 |
| Total, other adverse events | Oral Antidiabetic Drug | 15 | 984 |
| Total, serious adverse events | Liraglutide 1.8 mg | 92 | 980 |
| Total, serious adverse events | Oral Antidiabetic Drug | 81 | 984 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 1.8 mg vs Oral Antidiabetic Drug: deaths from any cause | Trial comparisons |
| Liraglutide 1.8 mg vs Oral Antidiabetic Drug: 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/NCT02730377
GET https://conductscience.org/api/trials/v1/NCT02730377/registered?page=2