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A Study in Patients with Type 2 Diabetes

Conditions
Type 2 Diabetes Mellitus
MedDRA version: 14.1Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Registration Number
EUCTR2009-014803-30-SE
Lead Sponsor
Eli Lilly & Company - Indianapolis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
837
Inclusion Criteria

Men and non-pregnant women aged =18 years with type 2 diabetes mellitus who have been treated with 1 oral antihyperglycemic medication, with a screening HbA1c =7.0% and 11% or patients who have been treated with 2 or 3 oral antihyperglycemic medications with a screening HbA1c =7.0% and 10%.

See protocol for full inclusion criteria.
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 837
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with type 1 diabetes mellitus; with HbA1c =6.5%; patients treated chronically with insulin therapy for the treatment of diabetes at any time in the past.

See protocol for full exclusion criteria

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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