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Detemir

Phase 3

Diabetes Mellitus Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Nov 11, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment442

FDA Designations

No designations recorded

Clinical trial landscape

Detemir · 1 trial · 1 indication

Phase 3 1
NCT00494013Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)Diabetes Mellitus Type 2
COMPLETED442 Analytics
PHASE3COMPLETED
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
Diabetes Mellitus Type 2
NCT00494013442
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Study Endpoints

Primary Endpoints

Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c)
Baseline, 24 Weeks

Secondary Endpoints

Actual and Change From Baseline Hemoglobin A1c (HbA1c) Value at 12 Weeks and at 24 Weeks
Baseline, 12 Weeks, 24 Weeks
Percentage of Patients With HbA1c <7.0% and HbA1c < or = 6.5% at Endpoint
24 Weeks
Glycemic Variability
24 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin Lispro Protamine SuspensionEXPERIMENTALInsulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
DetemirACTIVE_COMPARATORDetemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

Interventions

NameTypeDescription
Insulin Lispro Protamine SuspensionDRUGPatient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
DetemirDRUGPatient specific dose administered subcutaneously once or twice daily x 24 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites56

Inclusion Criteria: 1. Have type 2 diabetes mellitus for at least 1 year. 2. Are at least 18 years old. 3. Have been receiving oral antihyperglycemic medications (OAMs), without insulin, for at least 3 months immediately prior to the study and have been on stable doses of at least 2 of the followin...

Countries:United StatesArgentinaHungaryIndiaMexicoPolandSouth KoreaSpainTaiwan
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Frequently asked questions about Detemir

What is Detemir used for in Diabetes Mellitus Type 2?

Detemir is an investigational small molecule being developed for the treatment of Diabetes Mellitus Type 2. It is designed to manage blood glucose levels in patients with this condition. As of the latest data, Detemir is in Phase 3 clinical development and has not yet been approved by regulatory authorities.

Who makes Detemir?

Detemir is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and efficacy of Detemir for the treatment of Diabetes Mellitus Type 2.

What phase is Detemir in?

Detemir is currently in Phase 3 clinical development. This phase involves large-scale studies to confirm its efficacy and monitor adverse reactions in patients with Diabetes Mellitus Type 2. Detemir is still investigational and has not received FDA approval.

What clinical trials is Detemir in?

Detemir has been studied in one completed Phase 3 clinical trial with the identifier NCT00494013. This trial, titled 'Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)', enrolled 442 participants across multiple countries including the United States, Argentina, Hungary, India, Mexico, Poland, South Korea, Spain, and Taiwan.

Is Detemir FDA approved?

Detemir is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of Diabetes Mellitus Type 2. The drug has completed one clinical trial, but regulatory approval has not been granted.