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Diabetes Mellitus, Type 2Phase 4NCT00384215

Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin

A Phase 4 study testing insulin glargine [rDNA origin] injection in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in United States.

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

This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
insulin glargine [rDNA origin] injection
Type of treatment
Injection or infusion
How many people
352 participants
Where
1 siteUnited States
Study dates
Dec 2001to Feb 2005
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 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of type 2 diabetes mellitus for at least six months
  • Continuous treatment with at least 1g metformin or half maximally labeled dose of a SU daily for at least three months
  • HbA1c >/= 8 % and </= 12%, inclusive, as measured at screening week
  • Willingness to accept, and demonstrated ability to inject insulin glargine therapy
  • Demonstrated ability and willingness to perform SMBG using a plasma-referenced glucose meter at least twice a day
  • Ability to understand and willingness to adhere to and be compliant with the study protocol

Who cannot join

  • Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months
  • Congestive heart failure requiring pharmacological treatment
  • Impaired renal function, as shown by but not limited to serum creatinine >/= 1.5 mg/dl (133µmol/L) for males, or >/= 1.4 mg/dl (124 µmol/L) for females
  • Treatment with non-selective beta-blockers (including ocular)
  • Acute infection
  • History of or presence of signs of significant peripheral edema
Show all 22Show fewer
  • Acute or chronic or history of metabolic acidosis, including diabetic ketoacidosis
  • Planned radiological examinations requiring administration of contrasting agents
  • Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range
  • History of hypoglycemia unawareness
  • Pregnant or breastfeeding females
  • Failure to use adequate contraception (women of current reproductive potential only)
  • BMI < 25 kg/(m)(m)
  • Treatment with systemic steroids or large doses of inhaled steroids
  • Treatment with any diabetes medication other than the medications required by this study
  • Use of an investigational drug within the previous month
  • Known hypersensitivity to insulin glargine, pioglitazone or any of the components of insulin glargine and pioglitazone
  • Any malignancy within the last five years, except adequately treated basal cell carcinoma and adequately treated cervical carcinoma in situ.
  • Current addiction or alcohol abuse or history of substance or alcohol abuse within two years
  • Diagnosis of dementia
  • Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study or interpretation of study results
  • Inability to comply with study procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sanofi-Aventis

    Bridgewater, New Jersey, 08807

Other trials in United States

About this study

Official title: Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin: a Randomized, Open, Parallel Study

This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions.

Being tested
insulin glargine [rDNA origin] injection
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin glargine [rDNA origin] injectionDrug

What is being measured

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

  1. To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.

Secondary outcomes (8)

  1. Compare occurrence of hypoglycemia

  2. Compare change in body weight

  3. Compare change in FPG

  4. Compare change in serum lipid profile

  5. Compare percentage of subjects achieving HbA1c levels </= 7%

  6. Compare the time until an HbA1c </= 7% is achieved

  7. Compare change in HRQOL

  8. Compare cost of therapy for hyperglycemia treatment

Timeline

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

  1. First posted6 Oct 2006 (estimated)
  2. Study startDec 2001
  3. Study completionFeb 2005

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
None (open label)
Enrolment
352 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00384215
Sponsor's protocol ID
HOE901_4020
Status last verified
Jan 2011
First submitted
4 Oct 2006
Last updated
11 Jan 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin glargine [rDNA origin] injection in people with Diabetes Mellitus, Type 2, run by Sanofi at 1 site in United States.

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 6 inclusion and 22 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 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

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?

To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.. 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 NCT00384215.

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 11 Jan 2011.

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