Diabetes MellitusNCT00449553
Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone.
An observational study of Diabetes Mellitus, run by Takeda at 4 sites in 4 countries.
Trial summary
The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (QD), treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Pioglitazone and sulphonylurea and Pioglitazone and metformin
- Type of treatment
- Pill or oral medicine
- How many people
- 326 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jun 2001to Sep 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving pioglitazone therapy.
Who may be able to join
- Fulfills all requirements for treatment with pioglitazone.
- Willing to start treatment with pioglitazone.
Who cannot join
- Has previously participated in this study.
- Is currently taking or have taken oral antidiabetic medications other than sulfonylurea or metformin within the last 30 days.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Prospective Study of Associations of Changes in HbA1C and Fasting Blood Lipids Due to Treatment With Pioglitazone for 6 Months and Genetic Polymorphism's in PPAR-gamma
The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (QD), treatment.
Read the detailed description
The metabolic control in type 2 diabetes mellitus can be measured by means of glycosylated hemoglobin. A low value glycosylated hemoglobin indicates a good metabolic control, and has been shown to be associated with a better prognosis regarding diabetic complications. Type 2 diabetes is a disease with a profound genetic component. Peroxisome proliferator-activated receptor gamma is a transcription factor implicated in adipocyte differentiation, lipid and glucose metabolism. Peroxisome proliferator-activated receptor alfa is a transcription factor implicated in lipid oxidation and gluconeogenesis and is present in liver, kidney, heart, skeletal muscle and adipose tissue.
Pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors, members of the super family of ligand activated transcription factors. Specifically, thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism. These include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle.
This is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone.
- Conditions
- Diabetes Mellitus
- Being tested
- Pioglitazone and sulphonylurea, Pioglitazone and metformin
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Medical subject headings
- Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Diabetes Mellitus, Lipoatrophic, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone and sulphonylureaDrug
Also called ACTOS®, AD4833
Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Pioglitazone and sulphonylureaDrug
Also called ACTOS®, AD4833
Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months.
Pioglitazone and metforminDrug
Also called ACTOS®, AD4833
Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
Pioglitazone and metforminDrug
Also called ACTOS®, AD4833
Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone 15 mg QD + Sulphonylurea | Not described Receives: Drug: Pioglitazone and sulphonylurea | |
| Pioglitazone 30 mg QD + Sulphonylurea | Not described Receives: Drug: Pioglitazone and sulphonylurea | |
| Pioglitazone 15 mg QD + Metformin | Not described Receives: Drug: Pioglitazone and metformin | |
| Pioglitazone 30 mg QD + Metformin | Not described Receives: Drug: Pioglitazone and metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycosylated hemoglobin.
Measured: 6 months
Secondary outcomes (6)
Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).
Measured: End of Treatment
Change from baseline in Body Weight.
Measured: End of Treatment
Percentage of treatment responders defined as a patient with 0.6% decrease in HbA1C from baseline visit to final visit or accomplishment of a HbA1c value at or below 6.5%.
Measured: End of Treatment
Change from baseline in beta-cell function (Homeostasis model assessment).
Measured: End of Treatment
Change from baseline in insulin resistance (Homeostasis model assessment).
Measured: End of Treatment
Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).
Measured: End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startJun 2001
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- VP Clinical Science Strategy, Study director, Takeda Global Research and Developmnet Center Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449553
- Sponsor's protocol ID
- H6E-CP-GLAR
- Other IDs
- U1111-1114-2473
- Status last verified
- Feb 2012
- First submitted
- 1 Mar 2007
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Associations of Changes in HbA1C and Fasting Blood Lipids Due to Treatment With Pioglitazone for 6 Months and Genetic Polymorphism's in PPAR-gamma
- ClinicalTrials.gov ID
- NCT00449553
- Acronym / sponsor ID
- H6E-CP-GLAR
- Conditions
- Diabetes Mellitus
- Keywords
- Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Jun 2001
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 20 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (QD), treatment.
Detailed description
The metabolic control in type 2 diabetes mellitus can be measured by means of glycosylated hemoglobin. A low value glycosylated hemoglobin indicates a good metabolic control, and has been shown to be associated with a better prognosis regarding diabetic complications. Type 2 diabetes is a disease with a profound genetic component. Peroxisome proliferator-activated receptor gamma is a transcription factor implicated in adipocyte differentiation, lipid and glucose metabolism. Peroxisome proliferator-activated receptor alfa is a transcription factor implicated in lipid oxidation and gluconeogenesis and is present in liver, kidney, heart, skeletal muscle and adipose tissue.
Pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors, members of the super family of ligand activated transcription factors. Specifically, thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism. These include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle.
This is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone 15 mg QD + Sulphonylurea | – | Drug: Pioglitazone and sulphonylurea |
| Pioglitazone 30 mg QD + Sulphonylurea | – | Drug: Pioglitazone and sulphonylurea |
| Pioglitazone 15 mg QD + Metformin | – | Drug: Pioglitazone and metformin |
| Pioglitazone 30 mg QD + Metformin | – | Drug: Pioglitazone and metformin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving pioglitazone therapy.
Key inclusion criteria (2 listed)
- Fulfills all requirements for treatment with pioglitazone.
- Willing to start treatment with pioglitazone.
Key exclusion criteria (2 listed)
- Has previously participated in this study.
- Is currently taking or have taken oral antidiabetic medications other than sulfonylurea or metformin within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone and sulphonylureaAlso: ACTOS®, AD4833Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months. | Drug | Pioglitazone 15 mg QD + Sulphonylurea |
| Pioglitazone and sulphonylureaAlso: ACTOS®, AD4833Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months. | Drug | Pioglitazone 30 mg QD + Sulphonylurea |
| Pioglitazone and metforminAlso: ACTOS®, AD4833Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months. | Drug | Pioglitazone 15 mg QD + Metformin |
| Pioglitazone and metforminAlso: ACTOS®, AD4833Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months. | Drug | Pioglitazone 30 mg QD + Metformin |
Primary outcome
Change from baseline in glycosylated hemoglobin.
Time frame: 6 months
6 secondary outcomes
Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin).
Time frame: End of Treatment
Change from baseline in Body Weight.
Time frame: End of Treatment
Percentage of treatment responders defined as a patient with 0.6% decrease in HbA1C from baseline visit to final visit or accomplishment of a HbA1c value at or below 6.5%.
Time frame: End of Treatment
Change from baseline in beta-cell function (Homeostasis model assessment).
Time frame: End of Treatment
Change from baseline in insulin resistance (Homeostasis model assessment).
Time frame: End of Treatment
Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides).
Time frame: End of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- ACTOS® Package InsertLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VP Clinical Science Strategy study director
Takeda Global Research and Developmnet Center Inc
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Takeda at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Iceland, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in glycosylated hemoglobin. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2012.