inagliptin and metformin versus linagliptin in newly diagnosed, untreated Type 2 Diabetes

Phase 1

• Conditions: Type 2 Diabetes Mellitus; MedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-004158-24-SK
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

1. Male and female patients, 18 years of age or older at Visit 1 (Screen), with newly diagnosed (less than 12 months prior to Screen) T2DM.
2. Patients who are treatment-naïve, defined as absence of any oral antidiabetic therapy, injectable GLP-1 agonist/analogue, or insulin, and uncontrolled for the 12 weeks prior to randomisation.
3. Patients must have an HbA1c between 8.5% [69 millimoles per mole (mmol/mol)] and 12.0% (108 mmol/mol) at Visit 1 (Screen).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135

Exclusion Criteria

1. Acute coronary syndrome (non-ST Elevation Myocardial Infarction (STEMI), STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent.
2.Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal (ULN) in any of the following: alanine aminotransferase [ALT or called serum glutamic pyruvic transaminase (SGPT)], aspartate aminotransferase [AST or serum glutamic oxaloacetic transaminase (SGOT)], or alkaline phosphatase. Gilbert-Meulengracht syndrome (also known as conjugated hyperbilirubinemia, constitutional hepatic dysfunction, or familial nonhemolytic jaundice) will be permitted.
3.Impaired renal function, defined as calculated creatinine clearance of less than 60 milliters per minute (< 60 mL/min), by the Cockcroft-Gault Equation, as determined during Screen and/or Run-In Period.
4.Bariatric, gastric bypass, and other gastrointestinal surgeries (including all types of gastric banding and/or LapBand?) within the past two years.
5.Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
6.Medical history of pancreatitis.
7.Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, haemolytic anaemia).
8.Any contraindication to metformin IR and/or linagliptin therapies, according to local labels.
9.Treatment with anti-obesity drugs, including over-the-counter drugs such as Alli?(orlistat), 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight.
10.Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM.

Study & Design

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