Safety and Efficacy of BI 1356 as Monotherapy or in Combination in Type 2 DM - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00736099

Purpose

The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.

The treatment modalities are determined by the treatment in the blinded trial in which every patient was included previously as BI 1356 in monotherapy (patients in 1218.16 trial), BI 1356 in combination with pioglitazone (patients in 1218.15 trial), BI 1356 added to metformin background (patients in 1218.17 trial) or BI 1356 added to a background therapy of metformin in combination with a sulphonylurea (patients in 1218.18 study)

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: linagliptine 5 mg Drug: linagliptine 5 mg and pioglitazone 30 mg	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Incidence and intensity of AEs (e.g. oedema rate, weight gain) [ Time Frame: from baseline to study completion ] [ Designated as safety issue: Yes ]
Withdrawal due to AEs. [ Time Frame: from baseline to withdrawal ] [ Designated as safety issue: Yes ]
Clinically relevant new or worsening findings in physical examination as reported as adverse events [ Time Frame: from baseline to study completion ] [ Designated as safety issue: Yes ]
Changes from baseline in vital signs (blood pressure and pulse rate). [ Time Frame: from baseline to study completion ] [ Designated as safety issue: Yes ]
Clinically relevant new or worsening findings in 12-lead ECG as reported as adverse event [ Time Frame: from baseline to study completion ] [ Designated as safety issue: Yes ]
Changes from baseline in clinical laboratory assessments [ Time Frame: from baseline to study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The change from baseline in HbA1c. [ Time Frame: from baseline to study completion ] [ Designated as safety issue: No ]
The occurrence of a treat to target response, that is an HbA1c under treatment of < 7.0% after 78 weeks of treatment [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
The occurrence of a treat to target response, that is an HbA1c under treatment of < 6.5% after 78 weeks of treatment. [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
Occurrence of a relative efficacy response (HbA1c lowering by at least 0.5% after 78 weeks of treatment). [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
HbA1c reduction from baseline by visit over time [ Time Frame: from baseline to study completion ] [ Designated as safety issue: No ]
The change from baseline in fasting plasma glucose (FPG) after 78 weeks of treatment. [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
The change from baseline in fasting plasma glucose (FPG) by visit over time [ Time Frame: from baseline to study completion ] [ Designated as safety issue: No ]

Enrollment:	2122
Study Start Date:	August 2008
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: linagliptin 5 mg open label	Drug: linagliptine 5 mg safety and efficacy of linagliptine 5 mg open label
Experimental: linagliptin 5 mg and pioglitazone 30 mg open label	Drug: linagliptine 5 mg and pioglitazone 30 mg efficacy and safety of the combination linagliptine and pioglitazone

Eligibility

Ages Eligible for Study:	18 Years to 82 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Signed and dated written informed consent in accordance with the GCP and local legislation.
Patients completing the entire treatment period as a double blind trial whether or not they have been treated with rescue medication.

Exclusion criteria:

Patients who meet one or more of the withdrawal criteria of the treatment period of the previous trial.
Pre-menopausal women (last menstruation =< 1 year prior to signing 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, true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of birth control) and vasectomised partners. No exception will be made.
Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation.
Drug abuse which, in the opinion of the investigator, would interfere with trial participation.
Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of the trial medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736099

Show 231 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00736099 History of Changes
Other Study ID Numbers:	1218.40, 2008-000750-13
Study First Received:	August 14, 2008
Last Updated:	May 4, 2011
Health Authority:	Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica); Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna; Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada, Therapeutic Products Directorate; China: State Food and Drug Administration; Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Finland: Finnish Medicines Agency; Germany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn; Great Britain: Medicines and Healthcare products Regulatory Agency (MHRA); Greece: National Organization of Medicines (EOF) National Ethics Committee; Hungary: National Institute of Pharmacy, H-1051 Budapest; India: Drugs Controller General of India; Israel: Ministry of Health; Italy: Comitato di Bioetica Azienda Ospedaliero - Universitaria Pisana - PISA; Japan: Ministry of Health, Labor and Welfare; Korea, Republic of: Korea Food and Drug Administration; Malaysia: Drug Control Authority; Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS); Netherlands: Centrale Commissie Mensgebonden Onderzoek; New Zealand: Multi-Regional Ethics Committee / Medsafe; Philippines: Bureau of Food and Drugs; Poland: Registration Medicinal Product Medical Device Biocidal Product; Romania: National Medicines Agency, Bucharest; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; Spain: Agencia Espanola del Medicamento y Productos Sanitarios; Sweden: Sweden; Läkemedelsverket (Medical Product Agency) Region Etics Committee of Lund; Taiwan: Department of Health, Executive Yuan, Taiwan; Thailand: Food and Drug Administration; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012