Empagliflozin and the Preservation of Beta-cell Function in Women With Recent Gestational Diabetes (EMPA post-GDM)
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|ClinicalTrials.gov Identifier: NCT03215069|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2017
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gestational Diabetes||Drug: Empagliflozin 10 MG Drug: Placebo oral capsule||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Empagliflozin and the Preservation of Beta-cell Function in Women With Recent Gestational Diabetes|
|Estimated Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
Empagliflozin 10 mg PO daily
Drug: Empagliflozin 10 MG
Empagliflozin 10 mg PO daily
Placebo Comparator: Placebo
Matched placebo PO daily
Drug: Placebo oral capsule
Placebo PO daily
- Baseline-adjusted ISSI-2 at 48-weeks [ Time Frame: 48-weeks ]The primary outcome will be measured by ISSI-2. ISSI-2 is a validated OGTT-derived measure of beta-cell function analogous to the disposition index obtained from the intravenous glucose tolerance test. ISSI-2 is defined as the product of (i) insulin secretion measured by the ratio of the area-under-the-insulin-curve (AUCins) to the area-under-the-glucose curve (AUCgluc) and (ii) insulin sensitivity measured by the Matsuda index.
- Glucose tolerance status at 48-weeks [ Time Frame: 48-weeks ]Prevalence of dysglycemia on the OGTT at this visit.
- Baseline-adjusted ΔISR0-120/Δgluc0-120 × Matsuda index at 48 weeks [ Time Frame: 48-weeks ]and insulinogenic index/HOMA-IR.
- Baseline-adjusted insulinogenic index/HOMA-IR at 48-weeks [ Time Frame: 48-weeks ]Beta-cell function assessed by ΔISR0-120/Δgluc0-120 × Matsuda index at 48-weeks
- Body mass index at 48-weeks [ Time Frame: 48-weeks ]
- Insulin sensitivity at 48 weeks. [ Time Frame: 48-weeks ]Insulin sensitivity will be measured by Matsuda index on OGTT
- Central abdominal fat mass at 48 weeks [ Time Frame: 48-weeks ]Central abdominal fat mass will be measured by DXA assessment at L2-L4
- Quality of life at 48 weeks [ Time Frame: 48-weeks ]Quality of life will be assessed annually by the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36).
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): NCT03215069
|Contact: Caroline Kramer, MD PhD||4165864800 ext 7628||Caroline.Kramer@sinaihealthsystem.ca|