Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment

NCT01076842 | Completed Phase 4 DMC

• 1 other identifier: 08-13028
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the effectiveness of two different kinds of diabetes medications, insulin detemir (Levemir) and exenatide (Byetta), in improving blood sugar levels with little or no weight gain in patients with type 2 diabetes who are not well controlled on two or more oral (by mouth) diabetes medications. Both medications are given by injection with a very small needle just below the surface of your skin (called subcutaneous injection). The medication that you inject will be in addition to your oral medications.

Conditions

Diabetes Type 2

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the improvement in A1C goal measured in mean reduction in A1c levels over 24 weeks.

  1 month

Secondary Outcomes (1)

• Hypoglycemia weight waist-hip ratio frequency of hypoglycemia weight FBGL lipid levels CBC CMP biometric parameters of activity heat flux galvanic skin response heart rate level of physical activity and energy expenditure

  1 month

Study Arms (3)

A Levemir

ACTIVE COMPARATOR

Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl

Drug: Insulin-Levemir; Device: SenseWear Pro3® armband; Device: DexCom CGM

B Exenatide

ACTIVE COMPARATOR

Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continued until week 12.

Drug: Exenatide-Bayetta; Device: SenseWear Pro3® armband; Device: DexCom CGM

C Levemir+Exenatide

ACTIVE COMPARATOR

Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned.

Drug: Insulin-Levemir and Exenatide-Bayetta; Device: SenseWear Pro3® armband; Device: DexCom CGM

Interventions

Insulin-Levemir DRUG

Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl

Also known as: Levemir

A Levemir

Exenatide-Bayetta DRUG

Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continued until week 12.

Also known as: Exenatide

B Exenatide

Insulin-Levemir and Exenatide-Bayetta DRUG

Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned.

Also known as: Levemir+Exenatide

C Levemir+Exenatide

SenseWear Pro3® armband DEVICE

For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the SenseWear Pro3® armband for collection of ancillary physiologic data

Also known as: armband

A Levemir; B Exenatide; C Levemir+Exenatide

DexCom CGM DEVICE

For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the DexCom CGM for collection of continuous blood glucose concentrations.

Also known as: continuous glucose monitoring

A Levemir; B Exenatide; C Levemir+Exenatide

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of Type 2 DM for over six months
• A history of inadequate glycemic control (A1c \> 7.5% but \< 10%) despite treatment with 2 or more oral hypoglycemic agents
• years of age or older
• Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous 6 months)
• Naïve to insulin (no insulin for more than 14 days during the previous 6 months and none within 60 days of beginning the study)
• On at least ½ maximum or the greatest tolerable dose of their oral agents according to the label for at least 3 months
• BMI \< 40 kg/m2
• Willing to perform at least four finger stick blood glucose measurements each day

You may not qualify if:

• A diagnosis of Type 2 DM for less than six months
• An A1c of \< 7.5% or \> 10%
• Pregnancy as determined by a serum ß HCG.
• An unstable medical status
• Taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study
• Inability to read and write English
• Someone who is not likely to return for the follow-up because they or their sponsor is likely to have a permanent change of station or termination of service before completion of the protocol
• Unwilling to perform four finger stick blood glucose measurements each day
• Previous history of use of exenatide

Sponsors & Collaborators

• Novo Nordisk A/S: lead
• BodyMedia: collaborator

Study Sites (2)

MedStar Research Institute

Washington D.C., District of Columbia, 20003, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20306, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Insulin Detemir; Exenatide; Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Robert A Vigersky, MD

  WRAMC- Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: February 26, 2010
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

US (2)