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Assessment of Duration of Metabolic Effect of a Single Bolus of sc Injected Lantus Compared to NPH Insulin in Patients With Type 2 Diabetes

NCT00553020 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2007-11-02

No results posted yet for this study

Summary

To assess the duration of the metabolic effect of a sc injected single dose of either insulin glargine (LantusT) or NPH-insulin (ProtaphanT) on blood glucose control in patients with type 2 diabetes

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin glargine

Lantus (commercial formulation, Reference): 10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh) NPH-insulin (Protaphan) (Test): 10 mL vials (100 IU/mL) solution Dose: 0.3 IU per kg BW injected subcutaneously in the patients usual injection site (either abdomen or thigh)

Sponsors & Collaborators

Principal Investigators

  • Karim El-Haschimi · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Completion
2005-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00553020 on ClinicalTrials.gov