DRUG
Dapagliflozin
10mg
Status
Completed
Phase
Phase 4
Enrollment
90
Locations
1
Results
Posted
Publications
0
Study summary
In this study, the researchers hope to learn about SGLT2 inhibition on EGP (endogenous glucose production) and plasma glucose concentration in diabetic subjects. Researchers will examine diabetes and the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration.
This study will examine whether the coadministration of exenatide plus dapagliflozin will prevent the increase in EGP and result in an additive or even synergistic decrease in plasma glucose concentration compared to each agent alone.
Interventions
DRUG
10mg
DRUG
Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)
DRUG
Placebo for Dapagliflozin
Timeline
First posted
Dec 2, 2016
Study start
Dec 15, 2017
Primary completion
Jul 14, 2022
Study completion
Mar 19, 2023
Results posted
Jul 20, 2023
Registry updated
Jul 20, 2023
Outcomes
Change in Endogenous Glucose Production (EGP) After Acute Exposure to a Single Dose and Again After 16 Weeks of Treatment
Time frame · ACUTE [after a single dose of each study drug or placebo]
After screening, eligible subjects will receive a measurement of endogenous glucose production (EGP) with a prime-continuous infusion of 3-3H-glucose. The EGP measurement will be performed in the morning after a 10-12 hour overnight fast and will last 8.5 hours (from 6 AM to 2:30 PM). After a 3.5-hour tracer equilibration period, subjects (20 per group) will receive one of the following medications: (i) placebo; (ii) exenatide 5 ug subcutaneously; (iii) dapagliflozin (10 mg); and (iv) dapagliflozin 10 mg + exenatide 5 ug \[ACUTE STUDY\].
Change in Endogenous Glucose Production (EGP) After 16 Weeks of Treatment With Each Study Drug.
Time frame · 16 weeks
After screening, eligible subjects will receive a measurement of endogenous glucose production (EGP) with a prime-continuous infusion of 3-3H-glucose. The EGP measurement will be performed in the morning after a 10-12 hour overnight fast and will last 8.5 hours (from 6 AM to 2:30 PM). After a 3.5-hour tracer equilibration period, subjects (20 per group) will receive one of the following medications: (i) exenatide 5 ug subcutaneously; (ii) dapagliflozin (10 mg); and (iii) dapagliflozin 10 mg + exenatide 5 ug. Only three groups will be followed for 16 weeks since subjects are diabetic and placebo is not appropriate to use for this period. Again, subjects will be randomized to treatment with either exenatide, dapagliflozin or both drugs in combination. Repeat EGP will be measured again at 16 weeks as described above and data will be compared to respective "acute" studies.
Change in Fasting Plasma Glucose (FPG) Concentration
Time frame · 16 weeks
The change in (FPG) above baseline following administration of study interventions after 16 weeks of treatment with each study drug(s) compared to data obtained during the acute exposure. Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.
Change in Plasma Glucagon Concentration
Time frame · Baseline to 16 weeks
Measurement of change in plasma glucagon concentration after 16 weeks of treatment with each study drug(s) compared to acute exposure at baseline. Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.
Change in Plasma Insulin Concentration
Time frame · Baseline to 16 weeks
Measurement of change in plasma insulin concentration from baseline to 16 weeks following treatment with each study drug(s). Placebo arm was not included in this 16 week portion of the study, since subjects are diabetic. Only 3 arms of the study were conducted: (i) Byetta/Bydureon, (ii) Dapagliflozin (iii) Byetta/Bydureon plus Dapagliflozin.
Eligibility
Inclusion Criteria: 1. BMI = 25-35 kg/m\^2 2. must be drug naïve and/or on a stable dose (more than 3 months) of metformin and/or sulfonylurea 3. HbA1c \>7.0% and \<10.0% 4. Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis. 5. Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included. Exclusion Criteria: 1. Presence of significant systemic disease, heart problems including congestive heart failure, unstable angina or acute myocardial infarction, current infectious liver disease, acute stroke or transient ischemic attacks, history of pancreatitis, urosepsis and pyelonephritis, genital mycotic infections, or Type 1 diabetes mellitus 2. Any hepatic diseases in the past (infectious liver disease, viral hepatitis, toxic hepatic damage, jaundice of unknown etiology) or severe hepatic insufficiency and/or significant abnormal liver function tests defined as aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN 3. Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women or ≥1.5 mg/dl for men, or eGFR \<60 mL/min/1.73 m2) or history of unstable or rapidly progressing renal disease or end stage renal disease. 4. Uncontrolled thyroid disease , Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia 5. Significantly elevated triglyceride levels (fasting triglyceride \> 400 mg/dl), uncontrolled increased LDL-C 6. Untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm Hg) 7. Use of anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, , GnRH agonists, glucocorticoids, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finesteride, spironolactone, flutamide) stopped for at least 4 weeks 8. Prior history of a malignant disease requiring chemotherapy, prior history of bladder cancer regardless treatment 9. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status 10. History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit. 11. Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions 12. Known hypersensitivity or contraindications to use GLP1 receptor agonists (exenatide, liraglutide) 13. Use of , thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors stopped for at least 8 weeks. 14. Eating disorders (anorexia, bulimia) or gastrointestinal disorders 15. Suspected pregnancy (documented negative serum β-hCG test), desiring pregnancy in next 6 months, breastfeeding, or known pregnancy in last 2 months 16. Active history of illicit substance abuse or significant intake of alcohol 17. Having a history of bariatric surgery 18. Patient not willing to use two barrier method contraception during study period (unless sterilized or have an IUD) 19. Debilitating uncontrolled psychiatric disorder such as psychosis or neurological condition that might confound outcome variables 20. Inability or refusal to comply with protocol 21. Current participation or participation in an experimental drug study in previous three months
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
University of Texas Health Science Center
San Antonio, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
Related trials
Ohio State University · Obesity & Overweight · Diabetes (DM)
Not applicable
Recruiting
300
2026-07
Johns Hopkins University · Multiple Sclerosis
Phase 2
Recruiting
120
2026-07
AstraZeneca · Pancreatic Cancer
Not applicable
Recruiting
24,000
2026-06
Chinese University of Hong Kong · Cerebral Small Vessel Disease
Phase 2
Recruiting
110
2026-06
University Hospital, Bordeaux · Craniopharyngiomas · Hypothalamic Obesity
Phase 3
Completed
42
2026-05
Brigham and Women's Hospital · Cardiovascular Events · Type2 Diabetes
Not applicable
Active, not recruiting
781,430
2026-05
Assistance Publique Hopitaux De Marseille · Obesity · Diabetes
Phase 3
Completed
44
2026-05
University College, London · Parkinson's Disease
Phase 3
Completed
194
2026-05
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.