Status:
UNKNOWN
Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impaired Fasting Glucose
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
The Research Council of Norway
Norwegian Diabetes Association
Conditions:
Impaired Glucose Tolerance
Insulin Sensitivity
Eligibility:
FEMALE
18-60 years
Phase:
PHASE2
Brief Summary
This study will test the effect of four common oral anti-diabetic agents on hepatic insulin sensitivity in South Asian women with impaired glucose tolerance or impaired fasting glucose. In a 12-week, ...
Detailed Description
Background: South Asians (SA) have a high prevalence of type 2 diabetes (T2D). SA i Norway develop T2D approximately 10 years earlier than Nordic subjects (NO).T2D in SA is often poorly regulated with...
Eligibility Criteria
Inclusion
- Able and willing to give informed consent
- Woman ≥ 18 years of age
- Of South Asian origin
- Participated in the DIASA 1 study (i.e. has had previous gestational diabetes (GDM) in last pregnancy). A period of 3 months after the 3-year limit since childbirth after GDM is seen as acceptable for inclusion.
- Impaired glucose tolerance (2-hour glucose value ≥7.8 and \< 11.1 mmol/l) and/or impaired fasting glucose (fasting plasma glucose ≥ 6.1 and \< 7.0 mmol/l) diagnosed in DIASA 1
Exclusion
- Known type 2 diabetes
- Known type 1 diabetes
- Fasting or 2-hour glucose values outside the inclusion criteria if the subject according to protocol needs to undergo an OGTT at baseline in DIASA 3
- Pregnant or fully lactating at randomisation or planned during study period.
- Not willing to practice a highly effective birth control method\* prior to initial dose, during study and for 2 weeks after the last administration of study drug.
- Concomitant use of any antidiabetic medication
- Concomitant use of fibrates or rifampicin
- Radiological examinations iodine containing contrast the previous week before randomisation, or planned during the study period.
- Known serious illness such as cancer (except in situ carcinoma) during past 5 years.
- Previous radiation therapy directed towards the pelvic area.
- Heart failure New York Heart Association (NYHA) class I-IV.
- Estimated glomerulus filtration rate (eGFR) \< 60 ml/min/1,73m2
- Chronic liver disease with serum levels of aspartate aminotransferase (ASAT) or alanine amino transferase (ALAT) \> 5 x upper limit of normal (ULN) or known impaired liver function (INR \> 1.5, Albumin \< 20 g/l, Bilirubin \> 20 g/l.
- Active infectious disease at inclusion
- Use of systemic corticosteroids \> 14 days within last 3 months before inclusion
- Hypothyroidism where substitution with levothyroxine has not been stable for the last 3 months or with thyroid stimulating hormone (TSH) outside normal limits.
- A history of bullous pemphigoid
- A history of acute or chronic pancreatitis
- Previous or present acute metabolic acidosis.
- Known hypersensitivity to any of the active ingredients or additives in the study medication or placebo capsules.
- Macroscopic haematuria not previously examined
- History of major surgical procedures within 3 months prior to inclusion or planned during study period.
- Any condition which in the investigator's opinion would jeopardize the subject's safety or compliance with the protocol.
- Birth control methods which may be considered as highly effective: Methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system ( IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.
Key Trial Info
Start Date :
February 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04662866
Start Date
February 10 2021
End Date
October 1 2023
Last Update
April 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oslo University Hospital, Aker Hospital
Oslo, Norway, 0424, Nydalen