Treatment to Regress to Normoglycemia in Women with a Recent History of GDM

Ki vehet részt

• Female
• 18 - 45 years old (inclusive)
• History of gestational diabetes in most recent pregnancy
• 6 months - 10 years postpartum
• BMI ≥ 25 kg/m2
• Use of long-acting reversible contraception or bilateral tubal ligation
• Dysglycemia as determined by glycemic response to 75g, 2-hour OGTT: either impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT):; Fasting glucose 100-125mg/dL (inclusive) and/or; 120 minute glucose 140-199mg/dL (inclusive)
• Willingness to maintain physical activity level throughout study duration
• Willingness to standardize diet for 3 days prior to OGTT
• Ability to provide informed consent before any trial-related activities

Ki nem vehet részt

• Use of medications for anti-obesity or weight loss within four weeks of screening visit 1
• Current or recent past (within 3 months) participation in another experimental drug trial
• Previous randomization in this trial
• Receipt of any investigational drug within 6 months prior to this trial
• History of or presence of: eating disorder, malignant disease requiring chemotherapy, or debilitating psychiatric disorder such as psychosis or neurological condition that could confound outcome variables
• History of bariatric surgery
• Known or suspected allergy to trial medication, excipients, or related products
• Contraindications to study medications: patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Presence of significant systemic disease including: diabetes mellitus (type 1 or type 2), cardiac disease (e.g. congestive heart failure), renal impairment (e.g. serum creatinine levels ≥ 1.4 mg/dL or eGFR < 60), hepatic disease (including viral hepatitis, toxic hepatic damage, jaundice of unknown aetiology, or abnormal liver function tests), pancreatitis, uncontrolled thyroid disease (e.g. documented abnormal TSH), adrenal disease (including Cushing's syndrome, congenital adrenal hyperplasia), hyperlipidemia (fasting triglycerides > 399mg%), untreated or poorly controlled hypertension (resting blood pressure >159/94 mmHg)
• Use of medications for glucose regulation: insulin (e.g. Humalog, Novolog, Humulin), pramlintide, metiglinides, metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors within four weeks of screening visit 1
• Use of medications known to exacerbate glucose dysfunction (such as isotretinoin or corticosteroids) within four weeks of screening visit 1
• Body weight > 350lb
• Pregnant or the intention of becoming pregnant or not using adequate contraceptive measures
• Breastfeeding within 3 months of screening visit 1
• Post-menopausal
• Desiring pregnancy within study participation period or two months after participation ends (i.e. 10 months from enrolment)
• Use of tobacco products within past 6 months
• Substance or alcohol abuse