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Effect of GLP-1 Receptor Agonist, Exenatide on Glucosuria Induced Elevation in ENDOGENOUS GLUCOSE PRODUCTION (EGP)

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ClinicalTrials.gov Identifier: NCT02981069
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eugenio Cersosimo, The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin Drug: Exenatide Drug: Placebo Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of GLP-1 Receptor Agonist, Exenatide on Glucosuria Induced Elevation in ENDOGENOUS GLUCOSE PRODUCTION (EGP)
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Byetta / Bydureon

Exenatide:

4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc

Drug: Exenatide
Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)
Other Name: Byetta, Bydureon

Active Comparator: Dapagliflozin
4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg
Drug: Dapagliflozin
10mg
Other Name: Farxiga

Active Comparator: Byetta/Bydureon plus Dapagliflozin

Exenatide:

4 weeks Byetta, 5 to 10ug sc (daily) 12 weeks Bydureon 2mg sc PLUS

Dapagliflozin:

4 weeks Dapagliflozin, Farxiga, 10mg 12 weeks Dapagliflozin, Farxiga, 10mg

Drug: Dapagliflozin
10mg
Other Name: Farxiga

Drug: Exenatide
Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)
Other Name: Byetta, Bydureon

Placebo Comparator: Placebo
Placebo group (4 weeks and 12 weeks)
Drug: Placebo
Placebo for Dapagliflozin




Primary Outcome Measures :
  1. Change in Endogenous Glucose Production (EGP) for Dapagliflozin only [ Time Frame: 16 weeks ]
    The change in EGP above baseline following dapagliflozin alone

  2. Change in EGP for Dapagliflozin plus exenatide (Byetta) [ Time Frame: 16 weeks ]
    The change in EGP above baseline following dapagliflozin/exenatide (Byetta)

  3. Change in EGP for Dapagliflozin plus exenatide (Bydureon) [ Time Frame: 16 weeks ]
    The change in EGP above baseline following dapagliflozin/exenatide (bydureon)


Secondary Outcome Measures :
  1. Change in EGP for Exenatide (Byetta) vs dapagliflozin/exenatide [ Time Frame: 16 weeks ]
    The change in EGP above baseline following exenatide (byetta) alone versus dapagliflozin/exenatide (byetta)

  2. Change in EGP for dapagliflozin vs placebo [ Time Frame: 16 weeks ]
    The change in EGP above baseline following dapagliflozin alone versus the change in EGP following placebo.

  3. Change in EGP for exenatide (byetta) vs placebo [ Time Frame: 16 weeks ]
    The change in EGP above baseline following dapagliflozin alone, exenatide alone, and dapagliflozin/exenatide versus the change in EGP following placebo.

  4. Change in EGP for dapagliflozin/exenatide vs placebo [ Time Frame: 16 weeks ]
    The change in EGP above baseline following dapagliflozin/exenatide versus the change in EGP following placebo.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI = 25-35 kg/m^2
  • must be drug naïve and/or on a stable dose (more than 3 months) of metformin and/or sulfonylurea
  • HbA1c >7.0% and <10.0%
  • 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.
  • 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:

  • Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded
  • Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981069


Contacts
Contact: Eugenio Cersosimo, MD, PhD 210-358-7200 cersosimo@uthscsa.edu
Contact: Ralph DeFronzo, MD 210-567-6691 defronzo@uthscsa.edu

Locations
United States, Texas
University of Texas Health Science Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Eugenio Cersosimo, MD    210-358-7200    cersosimo@uthscsa.edu   
Contact: Ralph A DeFronzo, MD    210-567-6691    defronzo@uthscsa.edu   
Principal Investigator: Eugenio Cersosimo, MD, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
AstraZeneca
Investigators
Principal Investigator: Eugenio Cersosimo, MD,PhD The University of Texas Health Science Center at San Antonio

Responsible Party: Eugenio Cersosimo, Associate Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02981069     History of Changes
Other Study ID Numbers: HSC20160597H
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists