Phase 2
N=24
Title: Therapeutic Targets in African-American Youth With Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02960659 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in Absolute Gluconeogenesis From Baseline to 12 Weeks — 0.018; -0.050 mg/kg LBM/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liraglutide (Drug); Metformin (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Absolute Gluconeogenesis From Baseline to 12 Weeks |
0.018; -0.050 | — |
| SECONDARY Change in Glucose Production Rate From Baseline to 12 Weeks |
0.089; -0.101 | — |
| SECONDARY Change in GIP AUC During OGTT and Meal Absorption |
-4432; -1476 | — |
| SECONDARY Change in GLP-1 Area Under the Curve Concentrations (AUC) During OGTT and Meal Absorption |
— | — |
| SECONDARY Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks |
0.023; 0.020 | — |
| SECONDARY Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks |
0.86; 0.46 | — |
| SECONDARY Change in Insulin AUC Concentrations During an OGTT and Meal Absorption |
-6381; 47831 | — |
| SECONDARY Change in Glycerol Turnover From Baseline to 12 Weeks |
-0.057; -0.030 | — |
| SECONDARY Change in Palmitate Turnover From Baseline to 12 Weeks |
0.003; -0.18 | — |
Summary
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....
Eligibility Criteria
- INCLUSION CRITERIA:
- Youth must self-identify as African-American and identify both parents as African-American
- Age 12-25 years
- Pubertal or post-pubertal: Girls Tanner stage IV-V breast; Boys Testicular volume 11-25cc
- Diagnosis of type 2 diabetes of less than or equal to 5 years duration, as per American Diabetes Association Criteria
- Hemoglobin A1C three times the upper limit of normal.
- Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
- 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.
- Body weight greater than or equal to 450 lbs
- Body weight less than or equal to 58kg
- Serum triglyceride concentrations greater than or equal to 500mg/dl
- Hemoglobin concentration <10g/dL
Data sourced from ClinicalTrials.gov (NCT02960659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.