A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00467649
First received: April 27, 2007
Last updated: June 4, 2014
Last verified: June 2014
Results First Received: April 10, 2009  
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 Mellitus
Interventions: Drug: pramlintide acetate (Symlin)
Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])
Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group A (Phase 1 SYMLIN) SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
Group B (Phase 1 RA Insulin) Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Group C (Phase 2 SYMLIN) Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
Group D (Phase 2 SYMLIN+RA) Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
Group E (Phase 2 RA Insulin) Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
Group F (Phase 2 RA Insulin + SYMLIN) Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2

Participant Flow for 2 periods

Period 1:   Phase 1 (Randomized Population)
    Group A (Phase 1 SYMLIN)     Group B (Phase 1 RA Insulin)     Group C (Phase 2 SYMLIN)     Group D (Phase 2 SYMLIN+RA)     Group E (Phase 2 RA Insulin)     Group F (Phase 2 RA Insulin + SYMLIN)  
STARTED     57 [1]   56     0     0     0     0  
Intent to Treat     56     56     0     0     0     0  
COMPLETED     48     50     0     0     0     0  
NOT COMPLETED     9     6     0     0     0     0  
Adverse Event                 2                 0                 0                 0                 0                 0  
Investigator Decision                 1                 0                 0                 0                 0                 0  
Lost to Follow-up                 2                 4                 0                 0                 0                 0  
Withdrawal of Consent                 4                 2                 0                 0                 0                 0  
[1] One patient randomized to the SYMLIN group withdrew consent prior to receiving the first dose

Period 2:   Phase 2 (Intent-to-Treat Population)
    Group A (Phase 1 SYMLIN)     Group B (Phase 1 RA Insulin)     Group C (Phase 2 SYMLIN)     Group D (Phase 2 SYMLIN+RA)     Group E (Phase 2 RA Insulin)     Group F (Phase 2 RA Insulin + SYMLIN)  
STARTED     0     0     17     31     14     36  
COMPLETED     0     0     17     29     14     35  
NOT COMPLETED     0     0     0     2     0     1  
Lost to Follow-up                 0                 0                 0                 1                 0                 0  
Protocol Violation                 0                 0                 0                 1                 0                 0  
Withdrawal of Consent                 0                 0                 0                 0                 0                 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.
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Reporting Groups
  Description
Group A (Phase 1 SYMLIN) SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
Group B (Phase 1 RA Insulin) Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
Total Total of all reporting groups

Baseline Measures
    Group A (Phase 1 SYMLIN)     Group B (Phase 1 RA Insulin)     Total  
Number of Participants  
[units: participants]
  56     56     112  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     49     95  
>=65 years     10     7     17  
Age  
[units: years]
Mean ± Standard Deviation
  55.0  ± 11.35     53.6  ± 9.70     54.3  ± 10.53  
Gender  
[units: participants]
     
Female     22     19     41  
Male     34     37     71  
Region of Enrollment  
[units: participants]
     
United States     56     56     112  
Fasting Plasma Glucose  
[units: mg/dL]
Mean ± Standard Deviation
  155.1  ± 39.60     164.3  ± 49.61     159.7  ± 44.92  
Fasting Serum Lipids  
[units: mg/dL]
Mean ± Standard Deviation
     
Total Cholesterol     167.53  ± 47.054     169.86  ± 49.121     168.70  ± 47.903  
HDL     44.71  ± 11.893     41.77  ± 9.468     43.23  ± 10.790  
LDL     89.15  ± 38.386     90.41  ± 34.114     89.78  ± 36.133  
Triglycerides     174.13  ± 108.257     193.59  ± 159.508     183.95  ± 136.273  
HbA1c  
[units: Percent]
Mean ± Standard Deviation
  8.19  ± 0.840     8.25  ± 0.816     8.22  ± 0.825  
Waist Circumference  
[units: cm]
Mean ± Standard Deviation
  116.31  ± 15.427     117.15  ± 13.198     116.73  ± 14.297  
Weight  
[units: kg]
Mean ± Standard Deviation
  107.87  ± 21.893     103.46  ± 17.908     105.67  ± 20.032  



  Outcome Measures
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1.  Primary:   The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia   [ Time Frame: 24 Weeks ]

2.  Secondary:   Percentage of Patients Achieving HbA1c <=7% at Week 24   [ Time Frame: 24 Weeks ]

3.  Secondary:   Percentage of Patients With no Weight Gain at Week 24   [ Time Frame: 24 Weeks ]

4.  Secondary:   Percentage of Patients With a Severe Hypoglycemia Adverse Event   [ Time Frame: 24 Weeks ]

5.  Secondary:   Change in HbA1c From Baseline at Week 24   [ Time Frame: From Baseline to Week 24 ]

6.  Secondary:   Change in Body Weight From Baseline at Week 24   [ Time Frame: From Baseline to Week 24 ]

7.  Secondary:   Change in Waist Circumference From Baseline at Week 24   [ Time Frame: From Baseline to Week 24 ]

8.  Secondary:   Change in Fasting Plasma Glucose From Baseline at Week 24   [ Time Frame: From Baseline to Week 24 ]

9.  Secondary:   Fasting Serum Lipids Change From Baseline to Week 24   [ Time Frame: Baseline, week 24 ]

10.  Secondary:   Phase 2: Change in HbA1c at Week 36   [ Time Frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 ]

11.  Secondary:   Phase 2: Change in Body Weight at Week 36   [ Time Frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36 ]

12.  Other Pre-specified:   Hypoglycemia Adverse Events   [ Time Frame: 36 weeks ]


  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 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 more than 60 days but less than or equal to 180 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.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00467649     History of Changes
Other Study ID Numbers: ACA401
Study First Received: April 27, 2007
Results First Received: April 10, 2009
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board