A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01159938
First received: June 17, 2010
Last updated: February 21, 2014
Last verified: February 2014
Results First Received: February 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Diabetes Mellitus, Type 2
Intervention: Drug: Lispro

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with type 2 diabetes mellitus (T2DM) were randomized to either a high to low blood glucose sequence or a low to high blood glucose sequence dependent upon whether they received insulin lispro or not in the first study period. Participants were stratified into treatment arms based on their urinary albumin excretion rate (UAER).

Reporting Groups
  Description
Healthy Participants Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
T2DM With Albuminuria, High to Low T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
T2DM With Albuminuria, Low to High T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
T2DM With Normal UAER, High to Low T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
T2DM With Normal UAER, Low to High T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.

Participant Flow for 2 periods

Period 1:   First Study Period
    Healthy Participants     T2DM With Albuminuria, High to Low     T2DM With Albuminuria, Low to High     T2DM With Normal UAER, High to Low     T2DM With Normal UAER, Low to High  
STARTED     26     11     11     12     12  
Received at Least 1 Dose of Study Drug     0     11     11     12     12  
Safety and Efficacy Analysis Population     25 [1]   11     11 [2]   12     12  
COMPLETED     26     11     10     12     12  
NOT COMPLETED     0     0     1     0     0  
Protocol Violation (Microalbuminuria)                 0                 0                 1                 0                 0  
[1] One healthy participant completed study but was excluded from analyses (major protocol violation).
[2] Microalbuminuria relaxed with protocol amendment. T2DM albuminuria participant included in analyses.

Period 2:   Second Study Period
    Healthy Participants     T2DM With Albuminuria, High to Low     T2DM With Albuminuria, Low to High     T2DM With Normal UAER, High to Low     T2DM With Normal UAER, Low to High  
STARTED     0     11     10     12     12  
COMPLETED     0     11     10     12     12  
NOT COMPLETED     0     0     0     0     0  



  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 enrolled participants, with the exception of 1 healthy participant who completed the study but was later excluded from analyses due to major protocol violation.

Reporting Groups
  Description
Healthy Participants Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
T2DM With Albuminuria T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
T2DM With Normal UAER T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
Total Total of all reporting groups

Baseline Measures
    Healthy Participants     T2DM With Albuminuria     T2DM With Normal UAER     Total  
Number of Participants  
[units: participants]
  25     22     24     71  
Age  
[units: years]
Mean ± Standard Deviation
  58.8  ± 6.6     61.2  ± 4.9     63.7  ± 5.2     61.2  ± 5.9  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     25     22     24     71  
Race/Ethnicity, Customized  
[units: participants]
       
White     25     22     24     71  
Region of Enrollment  
[units: participants]
       
Finland     25     22     24     71  



  Outcome Measures
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1.  Primary:   Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast   [ Time Frame: 30 mins (pre-breakfast) ]

2.  Primary:   Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast   [ Time Frame: 60 mins (post-breakfast) ]

3.  Primary:   Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast   [ Time Frame: 120 mins (post-breakfast) ]

4.  Primary:   Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast   [ Time Frame: 180 mins (post-breakfast) ]

5.  Primary:   Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast   [ Time Frame: 240 mins (post-breakfast) ]

6.  Secondary:   Change in Pulse Wave Amplitude (PWA)   [ Time Frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) ]

7.  Secondary:   Change in Peripheral Artery Tonometry (PAT)   [ Time Frame: 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast) ]

8.  Secondary:   Change in QT Interval on Electrocardiogram (ECG)   [ Time Frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) ]

9.  Secondary:   Change in Blood Glucose (BG)   [ Time Frame: 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast) ]

10.  Secondary:   Change in Postprandial Pulse Wave Velocity (PWV)   [ Time Frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01159938     History of Changes
Other Study ID Numbers: 13087, F3Z-EW-IOPT
Study First Received: June 17, 2010
Results First Received: February 21, 2014
Last Updated: February 21, 2014
Health Authority: Finland: Finnish Medicines Agency