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Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
VA Office of Research and Development
Novo Nordisk A/S
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00998335
First received: October 19, 2009
Last updated: August 22, 2016
Last verified: June 2016
Results First Received: August 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Long-acting bedtime insulin detemir (Levemir)
Drug: Insulin detemir and pre-meal insulin aspart.

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Clinical Research Unit

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio to either Insulin detemir only arm or to Insulin detemir plus aspart.

Reporting Groups
  Description
Insulin Detemir Only

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months

Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

Insulin Detemir Plus Aspart

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.


Participant Flow for 2 periods

Period 1:   Initial Treatment (Months 0 - 3)
    Insulin Detemir Only     Insulin Detemir Plus Aspart  
STARTED     30     0  
COMPLETED     30     0  
NOT COMPLETED     0     0  

Period 2:   Randomized Period (Months 3 to 6)
    Insulin Detemir Only     Insulin Detemir Plus Aspart  
STARTED     8 [1]   22 [1]
COMPLETED     8     20  
NOT COMPLETED     0     2  
Withdrawal by Subject                 0                 2  
[1] All participants started in the "Insulin detemir only" arm. At month 3 subjects were randomized 2:1.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants were started in the "Insulin detemir only" arm. At week 12 the participants were randomized in a 2:1 ratio between the two arms.

Reporting Groups
  Description
Insulin Detemir Only

Patients with uncontrolled T2DM are treated with insulin detemir for 6 months

Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.

Insulin Detemir Plus Aspart

After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.

Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner.

Total Total of all reporting groups

Baseline Measures
    Insulin Detemir Only     Insulin Detemir Plus Aspart     Total  
Number of Participants  
[units: participants]
  8     22     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     22     30  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  50  (8)     59  (8)     57  (9)  
Gender  
[units: participants]
     
Female     0     3     3  
Male     8     19     27  
Region of Enrollment  
[units: participants]
     
United States     8     22     30  



  Outcome Measures
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1.  Primary:   Hepatic Steatosis   [ Time Frame: 3 and 6 months ]

2.  Secondary:   Metabolic Control as Measured by the A1c   [ Time Frame: 3 and 6 months ]

3.  Secondary:   Change in Insulin Secretion   [ Time Frame: 3 and 6 months. ]

4.  Secondary:   Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).   [ Time Frame: 3 and 6 months. ]

5.  Secondary:   Plasma Lipid Concentration.   [ Time Frame: 3 and 6 months. ]

6.  Secondary:   Change in Anthropometric Measure (Body Weight).   [ Time Frame: 3 and 6 months. ]

7.  Secondary:   Number of Hypoglycemic Events   [ Time Frame: 3 and 6 months ]

8.  Secondary:   Metabolic Control as Measured by the Fasting Plasma Glucose Concentration   [ Time Frame: 3 and 6 months ]

9.  Secondary:   Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.   [ Time Frame: 3 and 6 months ]

10.  Secondary:   Advanced Lipid Testing   [ Time Frame: 3 and 6 months ]

11.  Secondary:   Change in Anthropometric Measure (Body Mass Index [BMI]).   [ Time Frame: 3 and 6 months. ]

12.  Secondary:   Percent Change From Baseline in Vascular Inflammatory Markers   [ Time Frame: 3 and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kenneth Cusi
Organization: University of Florida
phone: 352-273-7236
e-mail: KCusi@ufl.edu



Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00998335     History of Changes
Other Study ID Numbers: 20060167
Study First Received: October 19, 2009
Results First Received: August 22, 2012
Last Updated: August 22, 2016
Health Authority: United States: Institutional Review Board