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Neutral protamine hagedorn insulin

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |Eli Lilly and Company|Last Updated: Jul 10, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment129

FDA Designations

No designations recorded

Clinical trial landscape

Neutral protamine hagedorn insulin · 1 trial · 1 indication

Phase 2 1
NCT00490854A Study for Patients With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2
COMPLETED129 Analytics
PHASE2COMPLETED
A Study for Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase
24, 48 and 76 weeks after Randomization

Secondary Endpoints

8-point SMBG profiles.
24, 48 and 76 weeks after Randomization
Mean change in HbA1c from baseline to the end.
24, 48 and 76 weeks after Randomization
Mean dosage of both preprandial and basal insulin.
24, 48 and 76 weeks after Randomization
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -

Interventions

NameTypeDescription
Human Insulin Inhalation PowderDRUGpatient specific, inhaled, at meals, 76 weeks
Neutral protamine hagedorn insulinDRUGpatient specific dose, injected, daily, 76 weeks
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Type 2 diabetes mellitus for at least 6 months 2. One or more oral antihyperglycemic medications for at least 12 weeks 3. HbA1c equal to or greater than 7.0%, and equal to or less than 10.5% 4. Nonsmokers, have not smoked for at least 6 months and agree not to smoke (cigars, ...

Countries:Japan
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Frequently asked questions about Neutral protamine hagedorn insulin

What is Neutral protamine hagedorn insulin used for in Type 2 Diabetes Mellitus?

Neutral protamine hagedorn insulin is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It is in Phase 2 clinical development, with one completed trial in Japan that enrolled 129 participants. The drug is not yet approved and remains under investigation.

Who makes Neutral protamine hagedorn insulin?

Neutral protamine hagedorn insulin is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Type 2 Diabetes Mellitus.

What phase is Neutral protamine hagedorn insulin in?

Neutral protamine hagedorn insulin is currently in Phase 2 clinical development. A Phase 2 trial for the drug has been completed, and it remains an investigational agent. It has not received regulatory approval and is still being evaluated for its potential use in treating Type 2 Diabetes Mellitus.

What clinical trials is Neutral protamine hagedorn insulin in?

Neutral protamine hagedorn insulin has one completed clinical trial registered under NCT00490854, titled 'A Study for Patients With Type 2 Diabetes Mellitus.' This Phase 2 study was conducted in Japan, enrolled 129 participants aged 20 years and older, and included both male and female patients.

Is Neutral protamine hagedorn insulin the same as NPH insulin?

Yes, Neutral protamine hagedorn insulin is commonly known as NPH insulin. It is an intermediate-acting insulin formulation used to manage blood sugar levels. In the context of this clinical development program, it is being investigated as a treatment for Type 2 Diabetes Mellitus.