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

NCT00135083 | Completed Phase 3

• 1 other identifier: HMR1964A_3511
• Study Type: interventional
• Target: 347
• Locations: 0 countries
• Sites: N/A

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 baseline to study week 24.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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.

  From baseline to study week 24.

Study Arms (3)

1

EXPERIMENTAL

Once daily: * Insulin glulisine Dosing: Supper, Lunch, Breakfast * Monitoring Needed at: Bedtime,Pre-Supper, Pre-Lunch

Drug: insulin glulisine

2

EXPERIMENTAL

Twice daily: * Insulin glulisine Dosing: Supper \& Lunch, Lunch \& Breakfast, Breakfast \& Supper * Monitoring Needed at: Bedtime \& Pre-Supper, Pre-Supper \& Pre-Lunch, Pre-Lunch \& Bedtime

Drug: insulin glulisine

3

EXPERIMENTAL

Twice daily: * Insulin glulisine Dosing: Supper, Lunch, Breakfast * Monitoring Needed at: Bedtime, Pre-Supper, Pre-Lunch

Drug: insulin glulisine

Interventions

insulin glulisine DRUG

* 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.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Related Publications (1)

• 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.

  PMID: 21324825 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Karen Barch, B.S.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 23, 2005
• First Posted: August 25, 2005
• Study Start: August 1, 2004
• Study Completion: November 1, 2007
• Last Updated: January 11, 2011

Record last verified: 2011-01