Primary outcomeMean· Baseline to 12 weeks
Change in Absolute Gluconeogenesis From Baseline to 12 Weeks
| Group | Value (mg/kg LBM/min) | Spread |
|---|---|---|
| Metformin | 0.018 | 0.34 |
| Metformin and Liraglutide | -0.050 | 0.24 |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataTitle: Therapeutic Targets in African-American Youth With Type 2 Diabetes
Overview
- Status
- Completed
- Phase
- Phase 1/2
- Enrollment
- 24 participants (actual)
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Nih
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 9 May 2017
- Primary completion
- 20 May 2022
- Completion
- 20 May 2022
- First posted
- 10 Nov 2016 (estimated)
- Last update posted
- 1 Aug 2023
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2017201820192020202120222023
- Ph 1/2
Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes
NCT029606599 May 2017 to 20 May 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Background: The pill metformin treats diabetes. But it does not work for all youth, especially African-Americans. The injectable Liraglutide treats type 2 diabetes in adults. Researchers want to understand how these drugs work and if they decrease excess sugar made by the liver in youth with type 2 diabetes. Objective: To test if using liraglutide and metformin are better than just metformin for decreasing excess sugar produced by the liver in African-American youth with type 2 diabetes. Eligibility: African-Americans ages 12-25 with type 2 diabetes Design: Visit 1: Participants will be screened with medical history, physical exam, and blood and urine tests. Participants will stop taking diabetes medicines for 1 week. They will learn how to check blood sugars at home twice a day. Visit 2: Overnight at the clinic. Participants will have: Vital signs taken. Pregnancy test. A thin plastic tube (IV catheter) be inserted in each forearm by needle. Blood drawn several times after drinking a sweet drink. X-ray of total body fat. Urine and stool collected. Breath tests while wearing a clear hood for up to 45 minutes. For several hours, participants can have only water. At 4 a.m. they will get sugar and fat with nonradioactive isotopes in one IV. Blood will be collected. Every 30 minutes from 9 a.m. to 2 p.m., they will drink small amounts of a shake and have blood drawn. Participants will be randomly assigned to take either both study drugs daily or just metformin daily. Visits 3-4: Participants will bring their blood sugar records and have blood tests. Visit 5, after 3 months: Repeat of visit 2....
Interventions
- LiraglutideDrug
- MetforminDrug
Arms2
Active comparator
Metformin
Standard release metformin (500 mg tablets) was initiated and titrated to maximum dose of metformin 1000 mg twice daily over 3 weeks and continued for 12 weeks
Experimental
Metformin and liraglutide
Standard release metformin (500 mg tablets) and liraglutide (0.6mg) were initiated and titrated to maximum dose of metformin 1000 mg twice daily, and liraglutide 1.8 mg daily over 3 weeks and continued for 12 weeks
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Absolute Gluconeogenesis From Baseline to 12 Weeks
Time frame · Baseline to 12 weeks
Registry description
Gluconeogenesis is measured using stable isotope tracers and is reported as mg/kg lean body mass (LBM) per minute
Secondary outcomes(8)
Change in Glucose Production Rate From Baseline to 12 Weeks
Time frame · Baseline to 12 weeks
Registry description
Glucose production rate is measured using stable isotope tracers and is reported as mg/kg LBM per minute.
Change in GIP AUC During OGTT and Meal Absorption
Time frame · Baseline to 12 weeks
Registry description
Change in glucose-dependent insulinotropic polypeptide (GIP) AUC during OGTT and meal absorption
Change in GLP-1 Area Under the Curve Concentrations (AUC) During OGTT and Meal Absorption
Time frame · Baseline to 12 weeks
Registry description
Change in Glucagon-like peptide-1 (GLP-1) area under the curve concentrations (AUC) during OGTT and meal absorption. These data cannot be reported at this time due to problems with the assay. It is expected that a new assay will be available by May 2024
Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks
Time frame · Baseline to 12 weeks
Registry description
Whole body insulin sensitivity is estimated from a model of glucose and insulin values obtained during the OGTT and is measured in 10\^-4 mU/ml/min
Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks
Time frame · Baseline to 12 weeks
Registry description
The Hepatic Insulin Sensitivity Index(HISI) is the reciprocal of glucose rate of appearance \[1000/(μmol/min)\] X insulin concentration \[mU/L\]
Change in Insulin AUC Concentrations During an OGTT and Meal Absorption
Time frame · Baseline to 12 weeks
Registry description
Change in insulin AUC as derived from 2-hour oral glucose tolerance test (OGTT). AUC is calculated using a trapezoidal rule. Higher AUC indicates higher insulin secretion
Change in Glycerol Turnover From Baseline to 12 Weeks
Time frame · Baseline to 12 weeks
Registry description
Glycerol turnover is measured using stable isotope tracers and is reported as mg/kg LBM per minute.
Change in Palmitate Turnover From Baseline to 12 Weeks
Time frame · Baseline to 12 weeks
Registry description
Palmitate turnover is measured using stable isotope tracers and is reported as mg/kg LBM per minute.
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· Baseline to 12 weeks
Change in Glucose Production Rate From Baseline to 12 Weeks
| Group | Value (mg/kg LBM/min) | Spread |
|---|---|---|
| Metformin | 0.089 | 0.28 |
| Metformin and Liraglutide | -0.101 | 0.24 |
Secondary outcomeMean· Baseline to 12 weeks
Change in GIP AUC During OGTT and Meal Absorption
| Group | Value (pg*ml/min) | Spread |
|---|---|---|
| Metformin | -4432 | 10550 |
| Metformin and Liraglutide | -1476 | 11798 |
Secondary outcome· Baseline to 12 weeks
Change in GLP-1 Area Under the Curve Concentrations (AUC) During OGTT and Meal Absorption
| Group | Value |
|---|
Secondary outcomeMean· Baseline to 12 weeks
Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks
| Group | Value (10^-4 mU/ml/min) | Spread |
|---|---|---|
| Metformin | 0.023 | 0.045 |
| Metformin and Liraglutide | 0.020 | 0.106 |
Secondary outcomeMean· Baseline to 12 weeks
Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks
| Group | Value (1000mU/L/(μmol/min)) | Spread |
|---|---|---|
| Metformin | 0.86 | 1.50 |
| Metformin and Liraglutide | 0.46 | 1.42 |
Secondary outcomeMean· Baseline to 12 weeks
Change in Insulin AUC Concentrations During an OGTT and Meal Absorption
| Group | Value (min*pmol/L) | Spread |
|---|---|---|
| Metformin | -6381 | 40108 |
| Metformin and Liraglutide | 47831 | 48143 |
Secondary outcomeMean· Baseline to 12 weeks
Change in Glycerol Turnover From Baseline to 12 Weeks
| Group | Value (mg/kg LBM/min) | Spread |
|---|---|---|
| Metformin | -0.057 | 0.131 |
| Metformin and Liraglutide | -0.030 | 0.104 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| MetforminStandard release metformin (500 mg tablets) was initiated and titrated to maximum dose of metformin 1000 mg twice daily over 3 weeks and continued for 12 weeks Metformin: Metformin 500mg oral tablet | 0 / 13 | 0 / 13 | 6 / 13 |
| Metformin and LiraglutideStandard release metformin (500 mg tablets) and liraglutide (0.6mg) were initiated and titrated to maximum dose of metformin 1000 mg twice daily, and liraglutide 1.8 mg daily over 3 weeks and continued for 12 weeks Liraglutide: Liraglutide (6mg/ml, 3ml ) solution for subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6mg, 1.2mg or 1.8mg. Metformin: Metformin 500mg oral tablet | 0 / 11 | 0 / 11 | 7 / 11 |
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
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2025
3 results
Systemic and gut microbiome changes with metformin and liraglutide in youth-onset type 2 diabetes: the MIGHTY study.
Glaros et al. 2025Gut microbescited by 21
PMID 41020378PMC12482426DOI 10.1080/19490976.2025.2558071PUB-41020378
CC03 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 12 Years up to 25 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
* INCLUSION CRITERIA:
1. Youth must self-identify as African-American and identify both parents as African-American
2. Age 12-25 years
3. Pubertal or post-pubertal: Girls Tanner stage IV-V breast; Boys Testicular volume 11-25cc
4. Diagnosis of type 2 diabetes of less than or equal to 5 years duration, as per American Diabetes Association Criteria
5. Hemoglobin A1C \<9% at study initiation
6. Negative to mild ketonuria without acidosis (negative or 1+ ketones on urinalysis)
7. Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65 and tyrosine phosphatase-related islet antigen 2 (IA-2))
8. Willing and able to take daily medications and check blood glucose levels at least twice per day or wear a continuous glucose monitoring device (CGM).
EXCLUSION CRITERIA:
1. Pregnancy or breastfeeding
2. Allergy to study medications
3. Allergy to milk protein
4. Chronic insulin therapy
5. Treatment with other medications which are known to affect the parameters under study (for example sodium glucose transporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-IV) inhibitors, non-selective beta blockers).
6. Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood glucose greater than or equal to 200mg/dL), and/or liver enzymes \> three times the upper limit of normal.
7. Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
8. Any other condition that, in the opinion of the investigators, will increase risk to the subject, or impede the accurate collection of study-related data.
9. Body weight greater than or equal to 450 lbs
10. Body weight less than or equal to 58kg
11. Serum triglyceride concentrations greater than or equal to 500mg/dl
12. Hemoglobin concentration \<10g/dL
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