Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment

NCT01076842 · Completed

Last updated 2026-05-28

This clinical trial tests different combinations of medications to see which is most effective at lowering blood sugar levels in adults with type 2 diabetes over a 24-week period.

Status Completed The study has finished.

Phase Phase 4 Monitors a drug already on the market.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 75 people Planned (estimated).

Who can join Ages 18–90 · all sexes

Timeline Started 2008-04 · est. completion 2011-04

Where 2 sites · United States

What this study is testing ClinicalTrials.gov NCT01076842 ↗

Description as written by the study sponsor.

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.

Treatments tested

Insulin-Levemir also known as Levemir Drug

Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl
Exenatide-Bayetta also known as Exenatide 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.
Insulin-Levemir and Exenatide-Bayetta also known as Levemir+Exenatide 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.
SenseWear Pro3® armband also known as 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
DexCom CGM also known as continuous glucose monitoring 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.

Main thing measured	The primary endpoint is the improvement in A1C goal measured in mean reduction in A1c levels over 24 weeks.
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01076842 ↗