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Diabetes MellitusPhase 4NCT00754403

Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes

A Phase 4 study testing Pioglitazone and metformin and Metformin in people with Diabetes Mellitus, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the efficacy of pioglitazone and metformin combination therapy, once daily (QD), on glycosylated hemoglobin in adults with type 2 diabetes. 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 metformin and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
312 participants
Where
No sites listed yet
Study dates
Jul 2005to Oct 2006
Phase
Phase 4
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

Who may be able to join

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
  • Diagnosed with type 2 diabetes and must have received appropriate counseling on lifestyle modification for type 2 diabetes including diet and exercise.
  • If taking metformin monotherapy or metformin and sulfonylurea combination therapy, has a glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 9.0% at screening and randomization.
  • If naïve or taking sulfonylurea monotherapy has an glycosylated hemoglobin greater than or equal to 8.5% and less than or equal to 10.0% at screening and greater than or equal to 7.5% and less than or equal to 9.0% at randomization.

Who cannot join

  • Has type 1 diabetes mellitus
  • Currently taking any thiazolidinedione or have taken any thiazolidinedione within 12 weeks prior to screening
  • Has congestive heart failure; has a triglyceride level greater than 500 mg per dL
  • Diastolic blood pressure greater than 100 mmHg or a systolic pressure greater than 160 mmHg
  • Body mass index greater than or equal to 42 kg/m2 (weight /height2)
  • Alanine transaminase level greater than or equal to 2.5 times the upper limit of normal, active liver disease, or jaundice.
Show all 17Show fewer
  • Male subjects who have a serum creatinine level greater than or equal to 1.5 mg per dL; female subjects who have a serum creatinine level greater than or equal to 1.4 mg per dL at the screening visit and at randomization.
  • Currently using insulin or has used insulin 3 months prior to Screening
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
  • Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • Chronically used oral or parenteral glucocorticoids (eg, prednisone, cortisone, hydrocortisone, dexamethasone)
  • Niacin greater than 200 mg per day, including niacin-containing products such as Advicor - 3 months prior to screening and during the study
  • Chronically used steroid-joint injections - 3 months prior to screening and during the study
  • Thiazolidinediones - 3 months prior to screening and during the study
  • Insulin - 3 months prior to screening
  • Other oral antidiabetic medications (eg, nateglinide [Starlix], acarbose [Precose]) with the exception of sulfonylurea - 3 months prior to screening and during the study
  • Metformin - Fortamet Stabilization and during the study

About this study

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects on Glycemic Control With Concomitantly Administered Pioglitazone HCl and Metformin HCl Extended Release (Fortamet®) in Subjects With Type 2 Diabetes

The purpose of this study is to determine the efficacy of pioglitazone and metformin combination therapy, once daily (QD), on glycosylated hemoglobin in adults with type 2 diabetes.

Read the detailed description

Pioglitazone (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones. The insulin-sensitizing actions of thiazolidinediones are at least partially mediated through the peroxisome proliferator-activated receptor gamma. These receptors are found primarily in adipocytes, vascular endothelial cells, monocytes, hepatocytes, and to a lesser extent myocytes.

Metformin was developed as an extended-release formulation of metformin hydrochloride and designed for once-a-day oral administration. Metformin is an antihyperglycemic agent, which improves glucose tolerance in patients with, type 2 diabetes, lowering both basal and postprandial plasma glucose.

On 15 July 1999, the FDA approved pioglitazone for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Pioglitazone is indicated for monotherapy and for use in combination with sulfonylureas, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control. On 26 November 2003, the FDA approved the combined use of pioglitazone with metformin.

This study is designed to evaluate the effect on glycemic control when pioglitazone and metformin are taken together. Individuals participating in this study will provide written informed consent and will be required to commit to a screening visit and approximately 5 additional visits at the study center. Study participation is anticipated to be about 31 weeks (or approximately 8 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms.

Being tested
Pioglitazone and metformin, 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 metforminDrug

    Also called Actos, AD-4833XT, Fortamet

    Pioglitazone 30 mg, tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.

  • MetforminDrug

    Also called Fortamet

    Pioglitazone placebo-matching tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.

Study groups in NCT00754403
Study groupRoleWhat they receive
Pioglitazone 30 mg QD + Metformin 1000 mg QDExperimentalNot described
Receives: Drug: Pioglitazone and metformin
Metformin 1000 mg QDActive comparatorNot described
Receives: Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from randomization in Glycosylated Hemoglobin

    Measured: Final Visit

Secondary outcomes (11)

  1. Change from randomization in Fasting Plasma Glucose

    Measured: Final Visit

  2. Change from randomization in Insulin

    Measured: Final Visit

  3. Change from randomization in Pro-Insulin

    Measured: Final Visit

  4. Change from randomization in Homeostasis Model Assessment

    Measured: Final Visit

  5. Change from randomization in Triglycerides

    Measured: Final Visit

  6. Change from randomization in Total Cholesterol

    Measured: Final Visit

  7. Change from randomization in Low-Density Lipoprotein Cholesterol

    Measured: Final Visit

  8. Change from randomization in high-density Lipoprotein Cholesterol

    Measured: Final Visit

  9. Change from randomization in Lipid Fractionation

    Measured: Final Visit

  10. Change from randomization in High Sensitivity C-Reactive Protein

    Measured: Final Visit

  11. Change from randomization in Creatine Phosphokinase

    Measured: Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2008 (estimated)
  2. Study startJul 2005
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00754403
Sponsor's protocol ID
01-05-TL-OPIXT-010
Other IDs
U1111-1114-2423
Status last verified
Jul 2010
First submitted
17 Sep 2008
Last updated
5 Jul 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pioglitazone and metformin and Metformin in people with Diabetes Mellitus, run by Takeda.

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 4 inclusion and 17 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 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 randomization in Glycosylated Hemoglobin (time frame: Final Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00754403.

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 5 Jul 2010.

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