Phase 1 and Phase 2 · Liraglutide

NCT02960659 trial results

Therapeutic Targets in African-American Youth With Type 2 Diabetes

Change in Absolute Gluconeogenesis From Baseline to 12 Weeks (mg/kg LBM/min), Baseline to 12 weeks. Metformin: 0.018; Metformin and Liraglutide: -0.050.

Participants: 24
Status: completed
Completed: 2022-05-20
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

As posted on ClinicalTrials.gov (NCT02960659), updated at source Aug 1, 2023. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02960659 measured first

Change in Absolute Gluconeogenesis From Baseline to 12 Weeksmg/kg LBM/min · Baseline to 12 weeks · mean

Metforminn=11	Metformin and Liraglutiden=10
0.018(0.34)	-0.050(0.24)

Side effects by arm

Side effects in NCT02960659

Percent of participants affected, 12 weeks. The most common events the registry lists.

Event	Metformin	Metformin and Liraglutide
Any serious event	0%	0%
Hypoglycemia	7.7%	27.3%
Vomiting	0%	27.3%
Abdominal pain	7.7%	18.2%
Diarrhea	15.4%	18.2%
Ankle fracture	0%	9.1%
Depression	0%	9.1%
Hyperglycemia	7.7%	9.1%
Infection	0%	9.1%
Nausea	7.7%	9.1%
Injection site reaction	0%	9.1%
Fall	7.7%	0%
Syncope	7.7%	0%

Secondary outcomes

What else it measured

Change in Glucose Production Rate From Baseline to 12 Weeksmg/kg LBM/min · Baseline to 12 weeks · mean

Metforminn=11	Metformin and Liraglutiden=10
0.089(0.28)	-0.101(0.24)

Change in GIP AUC During OGTT and Meal Absorptionpg*ml/min · Baseline to 12 weeks · mean

Metforminn=9	Metformin and Liraglutiden=10
-4432(10550)	-1476(11798)

Change in Whole Body Insulin Sensitivity From Baseline to 12 Weeks10^-4 mU/ml/min · Baseline to 12 weeks · mean

Metforminn=9	Metformin and Liraglutiden=10
0.023(0.045)	0.020(0.106)

Change in Hepatic Insulin Sensitivity Index From Baseline to 12 Weeks1000mU/L/(μmol/min) · Baseline to 12 weeks · mean

Metforminn=11	Metformin and Liraglutiden=10
0.86(1.50)	0.46(1.42)

Change in Insulin AUC Concentrations During an OGTT and Meal Absorptionmin*pmol/L · Baseline to 12 weeks · mean

Metforminn=9	Metformin and Liraglutiden=9
-6381(40108)	47831(48143)

Change in Glycerol Turnover From Baseline to 12 Weeksmg/kg LBM/min · Baseline to 12 weeks · mean

Metforminn=7	Metformin and Liraglutiden=5
-0.057(0.131)	-0.030(0.104)

Change in Palmitate Turnover From Baseline to 12 Weeksmg/kg LBM/min · Baseline to 12 weeks · mean

Metforminn=5	Metformin and Liraglutiden=5
0.003(0.24)	-0.18(0.21)

The trial

How NCT02960659 was run

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....

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
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

Who could join the trial

* 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

Published papers

Papers from NCT02960659

Glaros SB, Mishra SP, Jain S, Davis FS, Gabel SA, Mueller GA, Jarmusch AK, Mabundo L, Courville AB, Walter MF, Walter PJ, Overdahl KE, Yadav H, Chung ST. Systemic and gut microbiome changes with metformin and liraglutide in youth-onset type 2 diabetes: the MIGHTY study. Gut Microbes. 2025 Dec;17(1):2558071. doi: 10.1080/19490976.2025.2558071. Epub 2025 Sep 29.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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