Status:
COMPLETED
Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief 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 ba...
Eligibility Criteria
Inclusion
- Subjects with type 2 diabetes mellitus who have been using a stable combination oral antidiabetic therapy of 2 or 3 agents in different therapeutic classes for on at least 3 months will be enrolled in this study.
- 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%
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
347 Patients enrolled
Trial Details
Trial ID
NCT00135083
Start Date
August 1 2004
End Date
November 1 2007
Last Update
January 11 2011
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