Trial · NCT01794143
A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes
NCT01794143, Phase 3, Completed, GRADE Study Group; results first posted 2026-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes. Trials, record NCT01794143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01794143
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes
- NCT number
- NCT01794143
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,850 participants, actual
- Lead sponsor
- GRADE Study Group
- Conditions
- Type 2 Diabetes, Comparative Effectiveness of Glycemia-lowering Medications
- Interventions
- Sulfonylurea (glimepiride), DPP-4 inhibitor (sitagliptin), GLP-1 receptor agonist (liraglutide), Insulin (glargine)
- First posted
- 2013-02-18
- Last updated
- 2026-02-10
- Results first posted
- 2026-02-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Quarterly for 4 to 7 years | The primary metabolic outcome is the time to primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed, after addition of randomly assigned glucose-lowering medication at baseline. |
| Primary | HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Quarterly, 4-7 years | Number of participants who reached primary failure defined as an HbA1c\>=7% (53mmol/mol), subsequently confirmed, after addition of randomly assigned glucose-lowering medication at baseline. |
| Secondary | Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication. | Quarterly, 4-6 years | The secondary metabolic outcome is time to HbA1c\>7.5% (58 mmol/mol), confirmed, after addition of randomly assigned glucose-lowering medication at baseline. |
| Secondary | HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication. | Quarterly for 4 to 7 years | Number of participants who reached primary failure defined as an HbA1c\>7.5% (58 mmol/mol), confirmed, after addition of randomly assigned glucose-lowering medication at baseline. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Quarterly for 4 to 7 years | years | MEDIAN | |
| SECONDARY | Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication. | Quarterly, 4-6 years | years | MEDIAN | |
| PRIMARY | HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Quarterly, 4-7 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication. | Quarterly for 4 to 7 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Glargine Insulin U-100 | 1.3 | Inter-Quartile Range 0.6 to 2.5 | years | |
| Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Glimepiride | 1.3 | Inter-Quartile Range 0.6 to 2.3 | years | |
| Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Liraglutide | 1.5 | Inter-Quartile Range 0.6 to 2.7 | years | |
| Time to HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Sitagliptin | 0.8 | Inter-Quartile Range 0.5 to 2.0 | years | |
| Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication. | Glargine Insulin U-100 | 2.1 | Inter-Quartile Range 1.0 to 3.5 | years | |
| Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication. | Glimepiride | 2.0 | Inter-Quartile Range 1.1 to 3.3 | years | |
| Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication. | Liraglutide | 2.2 | Inter-Quartile Range 1.0 to 3.5 | years | |
| Time to HbA1c>7.5%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication. | Sitagliptin | 1.7 | Inter-Quartile Range 0.8 to 3.0 | years | |
| HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Glargine Insulin U-100 | 852 | Participants | ||
| HbA1c>=7%, While Receiving Metformin and the Randomly Assigned Glucose-lowering Study Medication | Glimepiride | 908 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glargine Insulin U-100 | 1,263 | |
| Overall Study | STARTED | Glimepiride | 1,254 | |
| Overall Study | STARTED | Liraglutide | 1,262 | |
| Overall Study | STARTED | Sitagliptin | 1,268 | |
| Overall Study | COMPLETED | Glargine Insulin U-100 | 1,138 | |
| Overall Study | COMPLETED | Glimepiride | 1,142 | |
| Overall Study | COMPLETED | Liraglutide | 1,156 | |
| Overall Study | COMPLETED | Sitagliptin | 1,144 | |
| Overall Study | NOT COMPLETED | Glargine Insulin U-100 | 125 | |
| Overall Study | NOT COMPLETED | Glimepiride | 112 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events175
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 |
|---|---|---|---|---|---|---|
| serious | Severe Hypoglycemia | Metabolism and nutrition disorders | Glargine Insulin U-100 | 17 | 1,263 | 21 |
| serious | Severe Hypoglycemia | Metabolism and nutrition disorders | Glimepiride | 28 | 1,254 | 38 |
| serious | Severe Hypoglycemia | Metabolism and nutrition disorders | Liraglutide | 12 | 1,262 | 13 |
| serious | Severe Hypoglycemia | Metabolism and nutrition disorders | Sitagliptin | 9 | 1,268 | 10 |
| serious | Severe Hypoglycemia | Metabolism and nutrition disorders | Study Run-In (Metformin Only) | 0 | 7,850 | 0 |
| serious | Heart failure | Cardiac disorders | Glargine Insulin U-100 | 26 | 1,263 | 35 |
| serious | Heart failure | Cardiac disorders | Glimepiride | 30 | 1,254 | 49 |
| serious | Heart failure | Cardiac disorders | Liraglutide | 14 | 1,262 | 18 |
| serious | Heart failure | Cardiac disorders | Sitagliptin | 30 | 1,268 | 56 |
| serious | Heart failure | Cardiac disorders | Study Run-In (Metformin Only) | 0 | 7,850 | 0 |
1 to 10 of 175Source ClinicalTrials.gov
See all 175 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glargine Insulin U-100 | 42 | 1,263 |
| Total, all-cause mortality | Glimepiride | 43 | 1,254 |
| Total, all-cause mortality | Liraglutide | 27 | 1,262 |
| Total, all-cause mortality | Sitagliptin | 41 | 1,268 |
| Total, all-cause mortality | Study Run-In (Metformin Only) | 0 | 7,850 |
| Total, other adverse events | Glargine Insulin U-100 | 0 | 1,263 |
| Total, other adverse events | Glimepiride | 0 | 1,254 |
| Total, other adverse events | Liraglutide | 0 | 1,262 |
| Total, other adverse events | Sitagliptin | 0 | 1,268 |
| Total, other adverse events | Study Run-In (Metformin Only) | 0 | 7,850 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers61
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DK098246 | Continuation of the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study | KRAUSE-STEINRAUF, HEIDI; LACHIN, JOHN M; NATHAN, DAVID M | GEORGE WASHINGTON UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2012 to 2022 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01794143
GET https://conductscience.org/api/trials/v1/NCT01794143/events?page=2