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

This study is not yet open for participant recruitment.
Verified December 2017 by Eugenio Cersosimo, The University of Texas Health Science Center at San Antonio
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981069
First Posted: December 2, 2016
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Eugenio Cersosimo, The University of Texas Health Science Center at San Antonio
  Purpose
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 Intervention Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin Drug: Exenatide Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Eugenio Cersosimo, The University of Texas Health Science Center at San Antonio:

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

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

  • 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:
  • 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)

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 80
Anticipated Study Start Date: January 31, 2018
Estimated Study Completion Date: January 31, 2020
Estimated Primary Completion Date: January 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
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 Not yet 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
  More Information

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 Submitted: November 30, 2016
First Posted: December 2, 2016
Last Update Posted: December 6, 2017
Last Verified: December 2017

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