Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Brief Summary: The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.


Options:
A: Inclusion Criteria:

1. Fasting plasma glucose 95-125 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1c ≤7.0%. There is no upper limit for the 2-hour glucose on OGTT.
2. Age 20-65 years
3. Body mass index (BMI) ≥25 kg/m2 but ≤50 kg/m2
4. Self-reported diabetes \<1 year in duration
5. Drug naïve (no prior to oral glucose lowering agent(s), insulin or other injectable glucose lowering agents)

Exclusion Criteria:

1. Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment
2. An underlying disease that affects glucose metabolism other than type 2 diabetes
3. Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
4. Active infections
5. Renal disease (serum creatinine \>1.4 mg/dl for men; \>1.3 mg/dl for women) or serum potassium abnormality (\<3.4 or \>5.5 mmol/l)
6. Anemia (hemoglobin \<11 g/dl in women, \<12 g/dl in men) or known coagulopathy
7. Cardiovascular disease, including uncontrolled hypertension. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies.
8. History of conditions that may be precipitated or exacerbated by a study drug:

   1. Pancreatitis
   2. Serum alanine transaminase (ALT) more than 3 times the upper limit of normal
   3. Excessive alcohol intake
   4. Suboptimally treated thyroid disease
   5. Medullary carcinoma of the thyroid or MEN-2 (in participant or a family history)
   6. Hypertriglyceridemia (\>400 mg/dl despite treatment)
9. Conditions or behaviors likely to affect the conduct of the RISE Study

   1. Unable or unwilling to give informed consent
   2. Unable to adequately communicate with clinic staff
   3. Another household member is a participant or staff member in RISE
   4. Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE
   5. Weight loss of \>5% in past three months for any reason other than post-partum weight loss. Participants taking weight loss drugs or using preparations taken for intended weight loss are excluded.
   6. Likely to move away from participating clinics in next two years
   7. Women of childbearing potential who are unwilling to use adequate contraception
   8. Current (or anticipated) pregnancy and lactation.
   9. Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE
10. Additional conditions may serve as criteria for exclusion at the discretion of the local site.
B: Inclusion Criteria for women with previous GDM:

* Informed oral and written consent
* Previous diagnosis of GDM according to current Danish guidelines (mainly PG concentrationa t 120 min after 75 g OGTT ≥ 9.0 mM) during pregnancy within the last 5 years
* Age \>18 years
* 25 kg/m2 \< BMI \< 45 kg/m2
* NGT, IFG and or IGT
* Safe contraception and negative pregnancy test

Exclusion Criteria for women with previous GDM:

* Patients with diabetes
* HbA1c ≥6.5%
* Patients with previous pancreatitis or previous neoplasia
* Pregnant or breast feeding women
* Anaemia (haemoglobin \<7 mM)
* Women planning to become pregnant within the next 5 years
* Women using other contraception than intrauterine device (IUD) or oral contraceptives. Women who do not use safe contraception will be offered application of an IUD.
* Women treated with statins, corticosteroids or other hormone therapy (except estrogens and gestagens)
* Ongoing abuse of alcohol or narcotics
* Impaired hepatic function (liver transaminases \>3 times upper normal limit)
* Impaired renal function (se-creatinine \>120 μM and/or albuminuria)
* Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg)
* Any condition that the investigator feels would interfere with trial participation
* Receiving any investigational drug within the last 3 months

Inclusion criteria for women without previous GDM:

* Informed oral and written consent
* Age \>18 years
* 25 kg/m2 \< BMI \< 45 kg/m2
* NGT
* Safe contraception and negative pregnancy test
* Pregnancy within the last ten years without GDM

Exclusion Criteria for women without previous GDM :

* Pregnant or breast feeding women
* Anaemia (haemoglobin \<7 mM)

Inclusion Criteria for women without previous GDM and without NAFLD:

* Informed oral and written consent
* Age \>18 years
* 25 kg/m2 \< BMI \< 45 kg/m2
* NGT
* At least one pregnancy witin the last ten years without GDM

Exclusion Criteria for women without previous GDM and without NAFLD:

* Pregnant or breast feeding women
* Anaemia (haemoglobin \<7 mM)
* Steatosis as assessed by ultrasound scanning
* Recieving any investigational drug within the last 3 months
* Any condition that the investigator feels would interfere with the trial participation

Inclusion Criteria for women with biopsi-verified NAFLD:

* Informed oral and written consent
* Women with known NAFLD or NASH
* Age \>18 years
* 25 kg/m2 \< BMI \< 45 kg/m2
* NGT
* At least one prior pregnancy

Exclusion Criteria for women with biopsi-verified NAFLD:

* women with established cirrhosis
* Pregnant or breast feedning women
* Anaemia (haemoglobin \<7 mM)
* Women treated with statins, corticosteroids or other hormone therapy ( except oestrogens and gestagens)
* Ongoing abuse of alcohol or narcotics
* Impaired renal function (se-creatinine \> 120 μM and/or albuminuria)
* Uncontrolled hypertension (systolic blood pressure \> 180 mmHg, diastolic blood presure \> 100 mmHg)
* Any condition that the investigator feels would interfere with trial participation
C: Inclusion Criteria:

* Blood glucose criteria must be met
* Body mass index (BMI) in the range 23-45

Exclusion Criteria:

* Diagnosis of diabetes
* Serious cardiovascular events within the past 6 months
* Use of insulin or any oral antidiabetic agent
* Other protocol-defined exclusion criteria may apply
D: Inclusion Criteria:

* Body Mass Index (BMI) of either 30 kg/m\^2 or more or BMI of less than 30 kg/m\^2 to 27 kg/m\^2 with presence of co-morbidities
* Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
* Previously undergone dietary weight loss and was not able to maintain reduced weight

Exclusion Criteria:

* Diagnosis of type 1 or type 2 diabetes
* Previous treatment with GLP-1 (glucagon-like peptide-1) receptor agonists (including liraglutide or exenatide), within the last 3 months
* Visit 1 thryoid stimulating hormone (TSH) outside of the range of 0.4-6.0 mIU/L
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
* Current or history of treatment with medications that may cause significant weight gain for at least 3 months before this trial
* Current participation in an organized diet reduction program (or within the last 3 months)
* Currently using or have used within three months before this trial: pramlintide, sibutramine, orlistat, zonisamide, topiramate, phenteremine, or metformin
* Previous surgical treatment for obesity (excluding liposuction if performed more than one year before trial entry)
* History of major depressive disorder or a PHQ-9 (Patient Health Questionnaire-9) score of more than 15 within the last 2 years or history of other severe psychiatric disorders or diagnosis of an eating disorder
* Subjects with a lifetime history of a suicide attempt or history of any suicidal behavior within the past month before entry into the trial

Answer: C