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Trial · Interventional

CompletedPhase 4Registry data

Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.

Overview

Status
Completed
Phase
Phase 4
Enrollment
67 participants (actual)
Sponsor
Consano Clinical Research, LLC · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
2 Jul 2019
Primary completion
1 Jun 2021
Completion
1 Jun 2021
First posted
31 May 2019
Last update posted
30 Aug 2021
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 4

    Effectiveness of Exenatide Plus Dapagliflozin on 24 Hour Glucose Variability Measured by CGM. A Proof of Concept.

    NCT03970044

    2 Jul 2019 to 1 Jun 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase IV, single site, randomized, open-label, parallel study comparing BYDUREON-BCise plus FARXIGA to BYDUREON-BCise alone and FARXIGA alone in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) on a stable dose of metformin alone.

Interventions

  • Exenatide 2 MGDrug
  • Dapagliflozin 10 MGDrug

Arms3

  • Experimental

    Exenatide 2 mg plus Dapagaliflozin 10 mg

    Exenatide extended release, 2 mg weekly, injected Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment

  • Active comparator

    Exenatide 2 mg

    Exenatide extended release, 2 mg weekly, injected 14 weeks of treatment

  • Active comparator

    Dapagaliflozin 10 mg

    Dapagliflozin, 10 mg once daily, orally 14 weeks of treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. MAGE

    Time frame · 14 weeks

    Registry description

    Compare the change in mean amplitude of glucose excursions from baseline to week 14

Secondary outcomes(7)
  1. Fasting Plasma Glucose

    Time frame · 14 weeks

    Registry description

    Change in fasting plasma glucose from baseline to week 14

  2. HbA1c

    Time frame · 14 weeks

    Registry description

    Change in HbA1c from baseline to week 14

  3. Weight

    Time frame · 14 weeks

    Registry description

    Change in weight from baseline to week 14

  4. Blood Pressure

    Time frame · 14 weeks

    Registry description

    Change in blood pressure from baseline to week 14

  5. Blood Glucose Variability

    Time frame · 14 weeks

    Registry description

    Variability in blood glucose from baseline to weeks 4, 10 and 14

  6. 24 Hour Mean Blood Glucose

    Time frame · 17 weeks

    Registry description

    Change in 24 mean blood glucose at multiple time points

  7. Blood Glucose Time In Range

    Time frame · 14 weeks

    Registry description

    Measure the proportion of time patients who had plasma glucose measurements of: \<70 mg/dL, \>70 mg/dL and \<180 mg/dL or \>180 mg/dL

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Willing and able to give informed written consent prior to any tudy specific procedures * Male or female, age 18 to 75 years * Diagnosis of T2DM * HbA1c \>7.5% and \<12% obtained at Screening * Treated with a stable dose of metformin alone (\>1500 mg/day) or max tolerated dose for at least 8 weeks prior to Screening * Body mass index (BMI) \<45 kg/m2 * Women of childbearing potential (WOCBP), defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), must agree to use 2 medically accepted, effective methods of birth control (e.g., hormonal contraceptive, barrier contraceptive with additional spermicide, tubal ligation, or an intrauterine device) prior to IP administration and continuing throughout the study and continuing for 10 weeks after the intake of the last dose of IP * Females who are postmenopausal must have been postmenopausal for \>1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the patient's follicle-stimulating hormone level must be checked and must be elevated and consistent with postmenopausal levels (i.e., \>40 IU/L); otherwise these patients must agree to use contraceptives listed above * Males who are sexually active with WOCBP must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) for the duration of the study (from the time they sign consent) and for 10 weeks following the last intake of IP to prevent pregnancy in a partner Exclusion Criteria: * Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) * Previous enrolment in the present study * Participation in a study within 30 days of planned enrolment in this study and at least 5 half-lives of the investigational product (IP) the patient received in a previous study * Positive serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of IP * Women who are pregnant, breastfeeding, or plan to become pregnant during the course of the study * History of taking OAD medications other than metformin, during the 8 weeks prior to screening, or have been on insulin therapy within 1 year of screening (with the exception of insulin therapy for rescue or use in gestational diabetes) * Treated with a GLP-1 receptor agonist within 6 months * Have a condition that is a contraindicated for use of exenatide (Bydureon BCise), dapagliflozin (Farxiga) or metformin per FDA approved prescribing information * History of diabetic ketoacidosis requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to screening * An estimated glomerular filtration rate (eGFR \<60 mL/min/1.73 m2 at Screening. A one-time repeat measurement is permitted at the discretion of the investigator, if the value is not consistent with prior values * History of acute pancreatitis associated or not with using an anti-diabetic drug therapy * Active liver disease and/or significant abnormal liver function defined as AST \> 2 x ULN and/or ALT \> 2x ULN and /or serum total bilirubin \> 2.0 mg/dl * History of frequent urinary and/or genital mycotic infections as determined by the investigator * Uncontrolled thyroid disease as determined by the investigator * Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * Significant cardiovascular history, as determined per Investigator's discretion * Ingestion of prescription or over-the-counter weight loss medications during the 3 months prior to screening * Have a known clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (eg, Lap-Band®) or chronically take drugs that directly reduce gastrointestinal motility * Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid therapy may be enrolled) * A history of prior amputation, peripheral vascular disease, or diabetic foot ulcers * History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed * Any condition or clinically significant abnormality, which in the Investigator's opinion, may render the patient unable to complete the study or which may pose significant risk to the patient or successful completion of the study.

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