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Diabetes Mellitus, Type 2Phase 3NCT00135083

Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus

A Phase 3 study testing insulin glulisine in people with Diabetes Mellitus, Type 2, run by Sanofi.

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 show the non-inferiority of insulin glulisine administered with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c (HbA1c), from baseline to study week 24. 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 glulisine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
347 participants
Where
No sites listed yet
Study dates
Aug 2004to Nov 2007
Phase
Phase 3
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

  • Male and female subjects 18 to 79 years of age with a diagnosis of type 2 diabetes mellitus for at least 6 months
  • Current treatment with a stable dose of 2 oral antidiabetic agents. The oral agents must be in 2 or 3 of the following 3 different classes:
  • Sulfonylurea: dosage greater than or equal to, one-half the maximum recommended dosage (eg, glimepiride >/= 4 mg; glipizide, including gastrointestinal therapeutic system [GITS], >/= 10 mg; glyburide >/= 10 mg; Glynase® >/=3 mg). The dosage must have been stable for at least 3 months prior to screening.
  • Biguanide: metformin dosage ≥ 1000 mg daily, including Glucophage XR®. The dosage must have been stable for at least 3 months prior to screening.
  • Thiazolidinedione (TZD): pioglitazone >/= 15 mg or rosiglitazone >/= 24 mg. The subject must have been using the same thiazolidinedione for at least 6 months,and the dosage must have been stable for at least 3 months prior to screening.
  • HbA1c >/= 8.0%
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  • Fasting C-peptide concentration > 0.27 nmol/L
  • Able and willing to perform self-monitoring of blood glucose (SMBG) up to 4 times a day
  • Able and willing to adhere to, and be compliant with, the study protocol
  • Able to read English or Spanish at the sixth-grade level in order to complete the subject reported outcomes component of the study
  • Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Who cannot join

  • Insulin use within the previous year
  • History of hypoglycemia unawareness
  • Acute or chronic, or history of, metabolic acidosis, including diabetic ketoacidosis
  • Impaired renal function as shown by, but not limited to, serum creatinine ≥ 3mg/dL. For subjects taking metformin, serum creatinine >/= 1.5 mg/dL for males, or >/= 1.4 mg/dL for females.
  • Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN)
  • Clinically significant peripheral edema if subject is using a TZD
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  • History of stroke, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, or angina pectoris, within the past 12 months
  • History of, or current, congestive heart failure (New York Heart Association [NYHA] III-IV) requiring pharmacologic treatment
  • Acute infection
  • Any malignancy within the past 5 years, with the exception of adequately treated basal or squamous cell carcinoma or adequately treated cervical carcinoma in situ
  • Current substance addiction or alcohol abuse or history of substance or alcohol abuse, within the past 2 years
  • Any clinically significant renal disease (other than proteinuria) or hepatic disease
  • Pregnant or lactating females
  • Dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Impaired dexterity or vision rendering the subject unable to administer injections
  • Known hypersensitivity to insulin glargine or insulin glulisine or any of the components of Lantus or Apidra
  • Any disease or condition (including abuse of illicit drugs, prescription medications, or alcohol) that, in the opinion of the investigator or sponsor, may interfere with the completion of the study
  • Unlikely to comply with the protocol, eg, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study
  • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof, directly involved in the conduct of the protocol
  • No subject will be allowed to enroll in this study more than once.

About this study

Official title: One Versus Two Versus Three Daily Rapid-acting Insulin Injections of APIDRA (Insulin Glulisine) as add-on to Lantus® and Oral Sensitizer Basal Therapy in Type 2 Diabetes: a Multicenter, Randomized, Parallel, Open-label Clinical Study

The purpose of this study is to show the non-inferiority of insulin glulisine administered with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c (HbA1c), from baseline to study week 24.

Being tested
insulin glulisine
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 glulisineDrug

    • Once Daily Insulin: Subjects will receive insulin glulisine administered once daily 0-15 minutes before the greatest glycemic impact meal of the day starting at one-tenth the total dose of insulin glargine with maximum starting dose of 10 Units, and with additional monitoring as shown in the table below.
    • Twice Daily: Subjects will receive insulin glulisine administered twice daily 0-15 minutes before the 2 greatest glycemic impact meals of the day starting at one-tenth the total dose of insulin glargine with a maximum starting dose of 10 Units, and with additional monitoring as shown in the table below.
    • Three Times Daily: Subjects will receive insulin glulisine administered 3 times daily 0-15 minutes before each meal of the day starting at one-tenth the total dose of insulin glargine with a maximum starting dose of 10 Units for each meal and additional monitoring as shown in the table below.
Study groups in NCT00135083
Study groupRoleWhat they receive
1ExperimentalOnce daily: * Insulin glulisine Dosing: Supper, Lunch, Breakfast * Monitoring Needed at: Bedtime,Pre-Supper, Pre-Lunch
Receives: Drug: insulin glulisine
2ExperimentalTwice daily: * Insulin glulisine Dosing: Supper \& Lunch, Lunch \& Breakfast, Breakfast \& Supper * Monitoring Needed at: Bedtime \& Pre-Supper, Pre-Supper \& Pre-Lunch, Pre-Lunch \& Bedtime
Receives: Drug: insulin glulisine
3ExperimentalTwice daily: * Insulin glulisine Dosing: Supper, Lunch, Breakfast * Monitoring Needed at: Bedtime, Pre-Supper, Pre-Lunch
Receives: Drug: insulin glulisine

What is being measured

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

  1. To show non-inferiority between treatment groups (insulin glargine plus insulin glulisine administered once a day, twice a day, or 3 times a day) in the change in glycemic control as measured by hemoglobin A1C.

    Measured: From baseline to study week 24.

Timeline

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

  1. First posted25 Aug 2005 (estimated)
  2. Study startAug 2004
  3. Study completionNov 2007

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
347 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00135083
Sponsor's protocol ID
HMR1964A_3511
Status last verified
Jan 2011
First submitted
23 Aug 2005
Last updated
11 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • Davidson MB, Raskin P, Tanenberg RJ, Vlajnic A, Hollander P. A stepwise approach to insulin therapy in patients with type 2 diabetes mellitus and basal insulin treatment failure. Endocr Pract. 2011 May-Jun;17(3):395-403. doi: 10.4158/EP10323.OR.

    PubMed 21324825

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin glulisine in people with Diabetes Mellitus, Type 2, run by Sanofi.

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 11 inclusion and 20 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.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 show non-inferiority between treatment groups (insulin glargine plus insulin glulisine administered once a day, twice a day, or 3 times a day) in the change in glycemic control as measured by hemoglobin A1C. (time frame: From baseline to study week 24.). 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 NCT00135083, which also lists 1 linked publication.

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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