A multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 weeks treatment with vildagliptin in type 2 diabetes mellitus patients = 70 years (drug-naive or inadequately controlled on oral agents).

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 13.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2010-022658-18-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-17
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

•age: = 70 years inclusive at Visit 1.
•female or male.
•patients with a confirmed diagnosis of T2DM: i/treated with a stable dose of OADs for at least 12 weeks prior to Visit 1. OADs that are allowed in this study are metformin, sulfonylurea (SU), thiazolidinediones (TZDs), a-glucosidase inhibitors or meglitinides, used either as monotherapy or in combination. ii/drug-naive patients diagnosed at least 12 weeks prior to Visit 1 (drug-naive is defined as no treatment with OADs for at least 12 weeks prior to Visit 1 and no treatment with OADs for > 3 consecutive months at any time in the past).
• HbA1c of = 7% and =10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled.
• body mass index (BMI) in the range of 19-45 kg/m2 inclusive at Visit 1.
• agreement to maintain a stable background medication dose throughout the study, if currently receiving OADs.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• FPG =270mg/dL (15mmol/L) at Visit 1.
• use of any of the following medications as assessed at Visit 1:
- prior use of insulin treatment (for = 7 consecutive days) in the preceding 12 weeks.
- use of DPP-4 inhibitors or GLP-1 analogues in the preceding 12 weeks.
- use of weight control products including weight-loss medications in the last 12 weeks.
- use of oral (=7 consecutive days) or chronic parenteral or intra-articular corticosteroid treatment within the last 8 weeks.
- treatment with growth hormone within the previous 6 months.
- treatment with any drug of known and frequent toxicity to a major organ, or that may interfere with the interpretation of the efficacy and safety data during the study.
• a history or evidence of any of the following:
- acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state (including coma) within the past 6 months.
- current diagnosis of congestive heart failure (NYHA III or IV).
- myocardial infarction within the past 6 months.
- coronary artery bypass surgery or percutaneous coronary intervention within the past 6 months.
- Stroke, transient ischemic attack, or reversible ischemic neurologic deficit within the past 6 months.
- unstable angina within the past 3 months.
- sustained and clinically relevant ventricular arrhythmia (patients with premature ventricular contractions if deemed not clinically significant may be enrolled).
- type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes (e.g. Cushing’s syndrome or acromegaly-associated diabetes).
- malignancy of an organ system (other than localized basal cell carcinoma of the skin) treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- hepatic disorder defined as:
- acute or chronic liver disease, evidence of hepatitis, cirrhosis or portal hypertension.
- history of imaging abnormalities that suggest liver disease (except hepatic steatosis), such as portal hypertension, capsule scalloping, cirrhosis.
- acute infections which may affect blood glucose control within the past 4 weeks.
•any of the following significant laboratory abnormalities as assessed at Visit 1
- clinically significant elevation or reduction of thyroid stimulating hormone (TSH) outside of the normal range.
- clinically significant renal dysfunction: glomerular filtration rate (GFR) <30mL/min/1.73m2 (via modification of diet in renal disease (MDRD) formula).
- alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN) at Visit 1, confirmed by repeat measure within 3 working days.
- total bilirubin > 2 x ULN and/or direct bilirubin > 1 x ULN confirmed by repeat measure within 3 working days.
- positive Hepatitis B surface antigen (HBsAg).
- positive Hepatitis C virus (HCV) antibody test (anti-HCV).
- elevated fasting triglycerides (TGs) > 500mg/dL (5.65mmol/L).
• any of the following electrocardiographic abnormalities at Visit 1
- second or third degree atrio-ventricular block without a pacemaker.
- long QT syndrome or QTc > 500ms.
•history of hypersensitivity to DPP-4 inhibitors.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified