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A New Oral Treatment For Type II Diabetes Mellitus

NCT ID: NCT00111800

Last Updated: 2018-03-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-28

Study Completion Date

2006-07-21

Brief Summary

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This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.

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Detailed Description

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A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Participants received oral dose of matching placebo capsule to denagliptin (DEN) once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 milligram (mg) once daily in the morning, 30 min prior to breakfast during the extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of placebo to the participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DEN 2.5 mg

Participants received oral dose of DEN 2.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 2.5 mg to the participants.

Group Type EXPERIMENTAL

DEN 2.5 mg

Intervention Type DRUG

DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DEN 7.5 mg

Participants received oral dose of DEN 7.5 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 7.5 mg to the participants.

Group Type EXPERIMENTAL

DEN 7.5 mg

Intervention Type DRUG

DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DEN 15 mg

Participants received oral dose of DEN 15 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 15 mg to the participants.

Group Type EXPERIMENTAL

DEN 15 mg

Intervention Type DRUG

DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DEN 30 mg

Participants received oral dose of DEN 30 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 30 mg to the participants.

Group Type EXPERIMENTAL

DEN 30 mg

Intervention Type DRUG

DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

DEN 45 mg

Participants received oral dose of DEN 45 mg capsule once daily in the morning, 30 min prior to breakfast during the main phase/extension phase 12-weeks treatment period. Participants were dispensed 3 bottles (bottle A, B and C) and were instructed to take 1 capsule daily from each bottle such that taking 1 capsule from each bottle daily provided the appropriate dose of DEN 45 mg to the participants.

Group Type EXPERIMENTAL

DEN 45 mg

Intervention Type DRUG

DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Interventions

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Placebo

Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Intervention Type DRUG

DEN 2.5 mg

DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Intervention Type DRUG

DEN 7.5 mg

DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Intervention Type DRUG

DEN 15 mg

DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Intervention Type DRUG

DEN 30 mg

DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Intervention Type DRUG

DEN 45 mg

DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.

Intervention Type DRUG

Other Intervention Names

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GW823093 2.5 mg GW823093 7.5 mg GW823093 15 mg GW823093 30 mg GW823093 45 mg

Eligibility Criteria

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Inclusion Criteria

* Women must not be pregnant and must not be breastfeeding.
* Have Type II diabetes.
* Not taking any medicine for diabetes, or taking one oral medicine for their diabetes.

Exclusion Criteria

* Have any underlying or significant active disease that would prevent the subject from safely participating in the trial by the judgement of the study doctor.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Long Beach, California, United States

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Pasadena, California, United States

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Denver, Colorado, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Sunset, Louisiana, United States

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Oxon Hill, Maryland, United States

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Las Vegas, Nevada, United States

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Pahrump, Nevada, United States

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Albany, New York, United States

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Buffalo, New York, United States

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Johnson City, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Kettering, Ohio, United States

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Jefferson Hills, Pennsylvania, United States

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Sewickley, Pennsylvania, United States

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Columbia, South Carolina, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Burke, Virginia, United States

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Bellingham, Washington, United States

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Tacoma, Washington, United States

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Vancouver, Washington, United States

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Coquitlam, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Gatineau, Quebec, Canada

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Mirabel, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Brno, , Czechia

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Cheb, , Czechia

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České Budějovice, , Czechia

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Liberec, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Třebíč, , Czechia

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Helsinki, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Bammental, Baden-Wurttemberg, Germany

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Deggingen, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Kippenheim, Baden-Wurttemberg, Germany

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Königsfeld im Schwarzwald, Baden-Wurttemberg, Germany

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Offenburg, Baden-Wurttemberg, Germany

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Sinsheim, Baden-Wurttemberg, Germany

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Stockach, Baden-Wurttemberg, Germany

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Weinheim, Baden-Wurttemberg, Germany

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Haag, Bavaria, Germany

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Höhenkirchen-Siegertsbrunn, Bavaria, Germany

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Bad Kreuznach, Hesse, Germany

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Hirschhorn, Hesse, Germany

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Kelkheim, Hesse, Germany

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Offenbach, Hesse, Germany

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Offenbach, Hesse, Germany

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Bad Lauterberg im Harz, Lower Saxony, Germany

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Lüneburg, Lower Saxony, Germany

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Tostedt, Lower Saxony, Germany

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Ingelheim, Rhineland-Palatinate, Germany

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Mainz, Rhineland-Palatinate, Germany

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Rhaunen, Rhineland-Palatinate, Germany

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Speyer, Rhineland-Palatinate, Germany

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Dresden, Saxony, Germany

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Dresden, Saxony, Germany

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Freital, Saxony, Germany

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Pirna, Saxony, Germany

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Schmiedeberg, Saxony, Germany

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Athens, , Greece

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Heraklion, Crete, , Greece

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Lávrio, , Greece

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Melíssia, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Jelgava, , Latvia

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Ogre, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Talsi, , Latvia

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Valmiera, , Latvia

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Ponce, , Puerto Rico

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Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Gothenburg, , Sweden

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Malmo, , Sweden

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GSK Investigational Site

Stockholm, , Sweden

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Countries

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United States Canada Czechia Finland Germany Greece Latvia Puerto Rico Romania Sweden

Study Documents

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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DPB100925

Identifier Type: -

Identifier Source: org_study_id

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