Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks in Type 2 Diabetic Patients With Insufficient Glycaemic Control Despite Metformin Therapy

NCT01215097 | Completed Phase 3 Results

• 1 other identifier: 1218.65
• Study Type: interventional
• Target: 306
• Locations: 3 countries
• Sites: 19

Brief Summary

In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment as add-on therapy to metformin in patients with type 2 diabetes and insufficient glycaemic control.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c Change From Baseline at Week 24

  Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.

  Baseline and at week 24

Secondary Outcomes (13)

• HbA1c Change From Baseline at Week 6

  Baseline and at week 6

• HbA1c Change From Baseline at Week 12

  Baseline and at week 12

• HbA1c Change From Baseline at Week 18

  Baseline and at week 18

• HbA1c Change From Baseline at Week 24(Chinese Only)

  Baseline and at 24 weeks

• FPG Change From Baseline at Week 24

  Baseline and at week 24

Study Arms (2)

Linagliptin

EXPERIMENTAL

once a day

Drug: Linagliptin

placebo

PLACEBO COMPARATOR

once a day

Drug: placebo

Interventions

Linagliptin DRUG

once a day

Linagliptin

placebo DRUG

once a day

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes prior to informed consent
• Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening):
• For patients undergoing wash out of previous medication: HbA1c =7.0 to =9.5% For patients not undergoing wash-out of previous medication: HbA1c =7.0 to =10.0%
• Glycosylated haemoglobin A1 (HbA1c) =7.0 to =10.0% at Visit 2 (Start of Run-in)
• Age = 18 and \< 80 years at Visit 1a (Screening)
• BMI (Body Mass Index) = 45 kg/m2 at Visit 1a (Screening)
• Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation

You may not qualify if:

• Myocardial infarction, stroke or TIA within 6 months prior to informed consent
• Impaired hepatic function, defined by serum levels of either Alanine transaminase,Aspartate transaminase, or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a
• Uncontrolled hyperglycaemia with a glucose level \>240 mg/dl (\>13.3 mmol/L) after an overnight fast during wash-out / placebo run-in and confirmed by a second measurement (not on the same day).
• Known hypersensitivity or allergy to the investigational product or its excipients or metformin or placebo
• Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent
• Treatment with an injectable Glucagon-like peptide- 1 (GLP-1) analogue (e.g. exenatide) , Dipeptidyl-Peptidase 4 (DPP-IV) inhibitor within 3 months prior to informed consent
• Treatment with insulin within 3 months prior to informed consent
• Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent.
• Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse
• Participation in another trial with an investigational drug within 2 months prior to informed consent
• Pre-menopausal women (last menstruation =1 year prior to informed consent) who:
• are nursing or pregnant,
• or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made.
• Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
• Renal failure or renal impairment (serum creatinine =1.5 mg/dl as determined at Visit 1a)

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Eli Lilly and Company: collaborator

Study Sites (19)

1218.65.86007 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1218.65.86011 Boehringer Ingelheim Investigational Site

Chongqing, China

Location

1218.65.86008 Boehringer Ingelheim Investigational Site

Dalian, China

Location

1218.65.86010 Boehringer Ingelheim Investigational Site

Fuzhou, China

Location

1218.65.86014 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1218.65.86005 Boehringer Ingelheim Investigational Site

Hefei, China

Location

1218.65.86006 Boehringer Ingelheim Investigational Site

Hefei, China

Location

1218.65.86012 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

1218.65.86001 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1218.65.86002 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1218.65.86003 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1218.65.86004 Boehringer Ingelheim Investigational Site

Suzhou, China

Location

1218.65.86015 Boehringer Ingelheim Investigational Site

Wenzhou, China

Location

1218.65.86009 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

1218.65.86013 Boehringer Ingelheim Investigational Site

Yangzhou, China

Location

1218.65.60002 Boehringer Ingelheim Investigational Site

Johor Bahru, Malaysia

Location

1218.65.60001 Boehringer Ingelheim Investigational Site

Kelantan, Malaysia

Location

1218.65.63001 Boehringer Ingelheim Investigational Site

Marikina City, Philippines

Location

1218.65.63002 Boehringer Ingelheim Investigational Site

San Juan City, Philippines

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 6, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: August 25, 2016
• Results First Posted: June 3, 2013

Record last verified: 2016-07

Locations

CN (15); MY (2); PH (2)