Trial · NCT01762046
Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans
NCT01762046, Phase 1, Completed, Massachusetts General Hospital; results first posted 2024-05-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans. Trials, record NCT01762046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01762046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans
- NCT number
- NCT01762046
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 1,033 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Glipizide, Metformin, Oral Glucose Tolerance Test
- First posted
- 2013-01-07
- Last updated
- 2026-05-06
- Results first posted
- 2024-05-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Glipizide Response as Measured by Area Over the Glucose Curve Between Time 0 and 240 Minutes According to Genotype | 0, 30, 60, 90, 120, 180 and 240 minutes post 5mg oral glipizide dose, Day 1 (visit 1) | Investigators will measure glucose levels at 0,30,60,90,120,180 and 240 minutes post 5mg Glipizide administration on Visit 1(Day1), and compare them by genotype at selected loci. |
| Primary | Glipizide Response as Measured by Area Under the Insulin Curve Between Time 0 and 240 Minutes According to Genotype | 0,30,60,90,120,180 and 240 minutes on Day 1 (Visit 1) | Investigators will measure insulin levels at 0,30,60,90,120,180 and 240 minutes post 5mg Glipizide administration on Visit 1(Day1), and compare them by genotype at selected loci. |
| Primary | Metformin Response - Change in Fasting Glucose From Visit 1 to Visit 2 | Day 1 (Visit 1) and Day 8 (Visit 2) | Investigators will measure the change in glycemic measures between Visit 1 (Day 1) and Visit 2 (Day 8) as an index of Metformin response, and compare them by genotype at selected loci. HOMA-IR is calculated from fasting glucose and fasting insulin values at both visit 1 (day 1) and visit 2 (day 8). HOMA-IR was calculated using (fasting glucose\*fasting insulin)/405) formula. |
| Primary | Metformin Response - Change in HOMA-IR From Visit 1 to Visit 2 | Day 1 (Visit 1) and Day 8 (Visit 2) | Investigators will measure the change in glycemic measures between Visit 1 (Day 1) and Visit 2 (Day 8) as an index of Metformin response, and compare them by genotype at selected loci. HOMA-IR is calculated from fasting glucose and fasting insulin values at both visit 1 (day 1) and visit 2 (day 8). HOMA-IR was calculated using (fasting glucose\*fasting insulin)/405) formula. A bigger difference/drop between visit 1 and visit 2 will show that metformin had an effect on insulin resistance index for these participants. The higher the HOMA-IR, the more insulin resistant you are. |
| Secondary | Incretin Levels | 0, 5, 10, 15, 30, 60 and 120 minutes, Day 8 (Visit 2) | Investigators will measure GLP-1 and GIP during the OGTT from 0 to 120 minutes of Visit 2, and compare them by genotype at selected loci. |
| Secondary | Proinsulin (Fasting) at Visit 1 and Visit 2 by Genotype for rs7903146 | Day 1 (Visit 1) and Day 8 (Visit 2) | Investigators will measure proinsulin levels at regular intervals during Visits 1 and 2, and compare them by genotype at selected loci. |
| Secondary | Fasting Glucagon at Visit 1 and Visit 2 by Genotype for rs7903146 | Day 1 (Visit 1) and Day 8 (Visit 2) | Investigators will measure glucagon levels at regular intervals during Visits 1 and 2, and compare them by genotype at selected loci. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Glipizide Response as Measured by Area Over the Glucose Curve Between Time 0 and 240 Minutes According to Genotype | 0, 30, 60, 90, 120, 180 and 240 minutes post 5mg oral glipizide dose, Day 1 (visit 1) | 1000 subjects were genotyped for SNP rs7903146 (in the TCF7L2 gene). We are showing Area over the curve for glucose that was measured between time 0 to 240 minutes. 10 subjects didn't pass the QC for genotype analysis. | mg/dl x time(minutes) | MEAN |
| PRIMARY | Glipizide Response as Measured by Area Under the Insulin Curve Between Time 0 and 240 Minutes According to Genotype | 0,30,60,90,120,180 and 240 minutes on Day 1 (Visit 1) | 1000 subjects were genotyped for SNP rs7903146 (in the TCF7L2 gene). We are showing Area under the curve for Insulin that was measured between time 0 to 240 minutes. 10 subjects didn't pass the QC for genotype analysis. | mU/L x time (minutes) | MEAN |
| PRIMARY | Metformin Response - Change in Fasting Glucose From Visit 1 to Visit 2 | Day 1 (Visit 1) and Day 8 (Visit 2) | We looked at fasting glucose at Visit 2 minus fasting glucose at visit 1 to see if there are differences by genotype at rs7903146 after Metformin treatment in the 1000 subjects in this study. 10 subjects didn't pass the QC for genotype analysis. | mg/dl | MEAN |
| PRIMARY | Metformin Response - Change in HOMA-IR From Visit 1 to Visit 2 | Day 1 (Visit 1) and Day 8 (Visit 2) | We looked at HOMA-IR at Visit 2 minus HOMA-IR at visit 1 to see if there are differences by genotype at rs7903146 after Metformin treatment in the 1000 subjects in this study. 10 subjects didn't pass the QC for genotype analysis. | (mg/dl*uU/ml²) | MEAN |
| SECONDARY | Incretin Levels | 0, 5, 10, 15, 30, 60 and 120 minutes, Day 8 (Visit 2) | We only measured GLP-1 and GIP in a subset of the study population. We are showing Area under the curve results for GLP-1 total, GLP-1 active, and GIP by genotype at rs7903146 in TCF7L2. | pmol/L x time (minutes) | MEAN |
| SECONDARY | Proinsulin (Fasting) at Visit 1 and Visit 2 by Genotype for rs7903146 | Day 1 (Visit 1) and Day 8 (Visit 2) | Fasting Proinsulin were measured only in a subset of study samples. We are showing fasting data at Day 1, Visit 1 and Day 8, Visit 2 by genotype at rs7903146 (in TCF7L2). | pmol/L | MEAN |
| SECONDARY | Metabolomics | Day 1 (Visit 1) and Day 8 (Visit 2) | |||
| SECONDARY | Vitamin D | Baseline | |||
| SECONDARY | Fasting Glucagon at Visit 1 and Visit 2 by Genotype for rs7903146 | Day 1 (Visit 1) and Day 8 (Visit 2) | Fasting glucagon were measured only in a subset of study samples. We are showing fasting data at Day 1, Visit 1 and Day 8, Visit 2 by genotype at rs7903146 (in TCF7L2). | pg/ml | MEAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Glipizide Response as Measured by Area Over the Glucose Curve Between Time 0 and 240 Minutes According to Genotype | Glipizide and Metformin | Area over the Glucose curve for TCF7L2 CC genotype | 4893.5 | Standard Deviation 2079.4 | mg/dl x time(minutes) |
| Glipizide Response as Measured by Area Over the Glucose Curve Between Time 0 and 240 Minutes According to Genotype | Glipizide and Metformin | Area over the Glucose curve for TCF7L2 CT genotype | 5032.6 | Standard Deviation 2161 | mg/dl x time(minutes) |
| Glipizide Response as Measured by Area Over the Glucose Curve Between Time 0 and 240 Minutes According to Genotype | Glipizide and Metformin | Area over the Glucose curve for TCF7L2 TT Genotype | 6011 | Standard Deviation 3204.8 | mg/dl x time(minutes) |
| Glipizide Response as Measured by Area Under the Insulin Curve Between Time 0 and 240 Minutes According to Genotype | Glipizide and Metformin | Area under the InsulinCurve for TCF7L2 CC genotype | 1141 | Standard Deviation 1910 | mU/L x time (minutes) |
| Glipizide Response as Measured by Area Under the Insulin Curve Between Time 0 and 240 Minutes According to Genotype | Glipizide and Metformin | Area under the InsulinCurve for TCF7L2 CT genotype | 1278 | Standard Deviation 1455 | mU/L x time (minutes) |
| Glipizide Response as Measured by Area Under the Insulin Curve Between Time 0 and 240 Minutes According to Genotype | Glipizide and Metformin | Area under the InsulinCurve for TCF7L2 TT genotype | 1400 | Standard Deviation 1447 | mU/L x time (minutes) |
| Metformin Response - Change in Fasting Glucose From Visit 1 to Visit 2 | Glipizide and Metformin | FastingGlucose V2-FastingGlucose V1 in CC Genotype | -2.1 | Standard Deviation 8.1 | mg/dl |
| Metformin Response - Change in Fasting Glucose From Visit 1 to Visit 2 | Glipizide and Metformin | FastingGlucose V2-FastingGlucose V1 in CT Genotype | -2.2 | Standard Deviation 8.2 | mg/dl |
| Metformin Response - Change in Fasting Glucose From Visit 1 to Visit 2 | Glipizide and Metformin | FastingGlucose V2-FastingGlucose V1 in TT Genotype | -6.1 | Standard Deviation 11 | mg/dl |
| Metformin Response - Change in HOMA-IR From Visit 1 to Visit 2 | Glipizide and Metformin | HOMA-IR Visit 1 - HOMA IR Visit 2 in CC Gentoype | 0.09 | Standard Deviation 1.9 | (mg/dl*uU/ml²) |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glipizide and Metformin | 1,033 | |
| Overall Study | COMPLETED | Glipizide and Metformin | 1,033 | |
| Overall Study | NOT COMPLETED | Glipizide and Metformin | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glipizide and Metformin | 0 | 1,033 |
| Total, other adverse events | Glipizide and Metformin | 0 | 1,033 |
| Total, serious adverse events | Glipizide and Metformin | 0 | 1,033 |
Source ClinicalTrials.gov
Papers3
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 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/NCT01762046
GET https://conductscience.org/api/trials/v1/NCT01762046/results?page=2