NCT00263965

TerminatedPhase 2

ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insuli...

AstraZeneca Source

AstraZeneca

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

D6160C09999

Secondary identifiers

EudraCT No 2004-000350-24

Study Type

interventional

Reported enrollment (type unavailable)

105

Locations

3 countries

Sites

3

Timeline

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 2006

Actual (reported)

Brief Summary

This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Reported enrollment (type unavailable): 105 participants
Study completion date: July 2006
Actual (reported)
Listed locations: 3 countries · 3 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 9, 2005
Actual (reported)
First Posted
December 12, 2005
Actual (reported)
Study Completion
July 2006
Actual (reported)

Last Updated: March 17, 2008
Status Verified: March 2008
Last Update Submitted: March 14, 2008

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.

Secondary Outcomes (10)

Hepatic and peripheral insulin sensitivity by assessing the M value during low (20 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp.
Basal hepatic glucose output measured by dideuterated glucose in the fasting state and during low insulin level clamp.
Plasma profile of glucose, insulin and lipids after a mixed meal
Calculated insulin secretion
Liver oxidation after a mixed meal
+5 more secondary outcomes

Interventions

TesaglitazarDrug

MetforminDrug

Dietary and lifestyle modification counselingBehavioral

Eligibility Criteria

Age30 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Provision of a written informed consent
Men or women who are 30-70 years of age

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (3)

Research Site

Helsinki, Finland

Research Site

Pisa, Italy

Research Site

Oxford, United Kingdom

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

tesaglitazarMetforminDiet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

AstraZeneca Galida Medical Science Director, MD
AstraZeneca
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

August 2005

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2006

Actual (reported)

NCT00263276

A Trial of BMS-512148 in Patients With Type 2 Diabetes Mellitus

Phase 2Completed

NCT00261352

GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Phase 3Terminated

NCT00266253

A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus Treated With a Stable Dose of Metformin

Phase 2Completed

NCT00111631

A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

Phase 2Completed

NCT00316758

A Study to Evaluate the Long-Term Safety and Tolerability of GK Activator (2) in Patients With Type 2 Diabetes.

Phase 2Completed

NCT00420511

Beta-Cell Function and Sitagliptin Trial (BEST)

Phase 2Completed

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Female patients: postmenopausal, hysterectomized

Diagnosed with type 2 diabetes

Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents

You may not qualify if:

Type 1 diabetes
New York Heart Association heart failure Class III or IV
Treatment with chronic insulin
History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells)
Creatinine levels above twice the normal range
Creatine kinase above 3 times the upper limit of normal
Received any investigational product in other clinical studies within 12 weeks
Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Contact the study team to confirm eligibility.

Nutritional Physiological Phenomena

Diet, Food, and Nutrition

Physiological Phenomena

Last Updated

March 17, 2008

Record last verified: 2008-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00263965
Data provider: ClinicalTrials.gov
Source updated: 2008-03-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:26 UTC

Locations

FI(1)GB(1)IT(1)

Study Stopped

ARAMIS: Actions of tesaglitazaR on fAt Metabolism and Insulin Sensitivity

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations