Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02022007
• Date of registration: 17/12/2013
• Prospective Registration: Yes
• Primary sponsor: Woman's
• Public title: Saxagliptin + Metformin Compared to Saxagliptin or Metformin Monotherapy in PCOS Women With Impaired Glucose Homeostasis BMS-AZPCOS
• Scientific title: Metabolic and Endocrine Effects of Combination of Metformin and DPP-4 Inhibitor Saxagliptin Compared to Saxagliptin or Metformin XR Monotherapy in Patients With PCOS and Impaired Glucose Regulation: A Single-blinded Randomized Pilot Study
• Date of first enrolment: March 2014
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02022007
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Karen Elkind-Hirsch, Ph.D.
• Affiliation: Woman's Hospital, Louisiana

Key inclusion & exclusion criteria

Inclusion Criteria:

- Females 18 years to 42 years of age with polycystic ovary syndrome(NIH PCOS criteria)
with prediabetic hyperglycemia determined by an 75 gram oral glucose tolerance test
(OGTT). Study subjects will be inclusive of PCOS women with impaired fasting glucose
(IFG), impaired glucose tolerance (IGT), or both (IFG/IGT).

- Written consent for participation in the study

Exclusion Criteria:

- Presence of significant systemic disease, heart problems including congestive heart
failure, history of pancreatitis, or diabetes mellitus (Type 1 or 2)

- Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of
unknown etiology), gallstones, abnormal liver function tests or renal impairment
(elevated serum creatinine levels or abnormal creatinine clearance)

- Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital
adrenal hyperplasia or hyperprolactinemia

- Significantly elevated triglyceride levels (fasting triglyceride > 400 mg %)

- Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg)

- Use of hormonal medications, drugs known to affect gastrointestinal motility,
lipid-lowering (statins, etc.) and/or anti-obesity drugs or medications that interfere
with carbohydrate metabolism (such as isotretinoin, hormonal contraceptives,
gonadotropin releasing hormone (GnRH) analogues, glucocorticoids, anabolic steroids,
C-19 progestins) for at least 8 weeks. Use of anti-androgens that act peripherally to
reduce hirsutism such as 5-alpha reductase inhibitors (finasteride, spironolactone,
flutamide) for at least 4 weeks

- Prior history of a malignant disease requiring chemotherapy

- Known hypersensitivity or contraindications to use of insulin sensitizers such as
metformin or thiazolidinediones

- History of hypersensitivity reaction to saxagliptin or other DPP-4 inhibitors (e.g.
anaphylaxis, angioedema, exfoliative skin conditions)

- Current use of metformin, thiazolidinediones, glucagon-like peptide -1 receptor
agonists, DPP-4 inhibitors, or weight loss medications (prescription or OTC) Patients
must stop use of insulin sensitizers or antidiabetic medicines such as metformin for
at least 4 weeks or thiazolidinediones, GLP1 agonists or DPPIV inhibitors for 8 weeks.

- Prior use of medication to treat diabetes except gestational diabetes

- Use of drugs known to exacerbate glucose tolerance

- Eating disorders (anorexia, bulimia) or gastrointestinal disorders

- Suspected pregnancy (documented negative serum pregnancy test), desiring pregnancy
during the study treatment interval, breastfeeding, or known pregnancy in last 2
months

- Active or prior history of substance abuse (smoke or tobacco use within past 3 years)
or significant intake of alcohol or history of alcoholism

- Patient not willing to use adequate barrier contraception during study period (unless
sterilized or have an IUD).

- Debilitating psychiatric disorder such as psychosis or neurological condition that
might confound outcome variables

- Inability or refusal to comply with protocol

- Not currently participating or having participated in an experimental drug study in
previous three months



Age minimum: 18 Years
Age maximum: 42 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Polycystic Ovary Syndrome

Disorder of Glucose Regulation

Intervention(s)

Drug: Saxagliptin-Metformin XR

Drug: Metformin XR

Drug: Saxagliptin

Primary Outcome(s)

Glucose Metabolism [Time Frame: 16 weeks]

Oral Disposition Index [Time Frame: 16 weeks]

Secondary Outcome(s)

Menstrual Cycle Interval at 16 Weeks [Time Frame: 16 weeks]

Waist Circumference at 16 Weeks [Time Frame: 16 weeks]

Pancreatic ß-cell Compensatory Function [Time Frame: 16 weeks]

Body Mass Index at 16 Weeks [Time Frame: 16 weeks]

Fasting Glucose [Time Frame: 16 weeks]

Matsuda Index of Insulin-Sensitivity (SI OGTT) [Time Frame: 16 weeks]

Mean Blood Glucose During the OGTT [Time Frame: 16 weeks]

Free Androgen Index (FAI) [Time Frame: 16 weeks]

Triglyceride (TRG) /HDL-cholesterol Ratio [Time Frame: 16 weeks]

Secondary ID(s)

BMS CV181-354

RP13-013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

AstraZeneca

Results

• Results available: Yes
• Date Posted: 28/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02022007