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.

Study NCT00467649 Information provided by Amylin Pharmaceuticals, Inc.

First Received: April 27, 2007 Last Updated: April 10, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: pramlintide acetate 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
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Reporting Groups

	Description
Group A (P1 SYMLIN)	SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
Group B (P1 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 (P2 SYMLIN)	Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
Group D (P2 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 (P2 RA Insulin)	Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
Group F (P2 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: Phase 1 (Intent-to-Treat Population)

	Group A (P1 SYMLIN)	Group B (P1 RA Insulin)
STARTED	56	56
COMPLETED	48	50
NOT COMPLETED	8	6
Adverse Event	2	0
Investigator Decision	1	0
Lost to Follow-up	2	4
Withdrawal of Consent	3	2

Period: Phase 2 (Intent-to-Treat Population)

	Group C (P2 SYMLIN)	Group D (P2 SYMLIN+RA)	Group E (P2 RA Insulin)	Group F (P2 RA Insulin + SYMLIN)
STARTED	17	31	14	36
COMPLETED	17	29	14	35
NOT COMPLETED	0	2	0	1
Lost to Follow-up	0	1	0	0
Protocol Violation	0	1	0	0
Withdrawal of Consent	0	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Group A (P1 SYMLIN)	SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
Group B (P1 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

Baseline Measures

	Group A (P1 SYMLIN)	Group B (P1 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: %] 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 Proportion of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia [ 24 Weeks ]

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2. Secondary:

Proportion of Patients Achieving HbA1c <=7% at Week 24 [ 24 Weeks ]

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3. Secondary:

Proportion of Patients With no Weight Gain at Week 24 [ 24 Weeks ]

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4. Secondary:

Proportion of Patients With a Severe Hypoglycemia Adverse Event [ 24 Weeks ]

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Measure Type	Secondary
Measure Title	Proportion of Patients With a Severe Hypoglycemia Adverse Event
Measure Description	This is a component of the primary endpoint
Time Frame	24 Weeks
Safety Issue	No

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.
Phase 1 Intent-to-Treat

Reporting Groups

	Description
Group A (P1 SYMLIN)	SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
Group B (P1 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

Measured Values

	Group A (P1 SYMLIN)	Group B (P1 RA Insulin)
Number of Participants Analyzed [units: participants]	56	56
Proportion of Patients With a Severe Hypoglycemia Adverse Event [units: %]	0.0	0.0

No statistical analysis provided for Proportion of Patients With a Severe Hypoglycemia Adverse Event

5. Secondary:

Change in HbA1c From Baseline at Week 24 [ 24 Weeks ]

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6. Secondary:

Change in Body Weight From Baseline at Week 24 [ 24 Weeks ]

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7. Secondary:

Change in Waist Circumference From Baseline [ 24 Weeks ]

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8. Secondary:

Change in Fasting Plasma Glucose From Baseline [ 24 Weeks ]

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9. Secondary:

Fasting Serum Lipids Change From Baseline at Week 24 [ 24 Weeks ]

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10. Secondary:

Phase 2: Change in HbA1c at Week 36 [ 36 Weeks ]

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11. Secondary:

Phase 2: Change in Body Weight at Week 36 [ 36 Weeks ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	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
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Amylin Pharmaceuticals Inc
e-mail: clinicaltrials@amylin.com

No publications provided

Responsible Party:	Amylin Pharmaceuticals ( Lisa Porter, MD, Study Director )
Study ID Numbers:	ACA401
Study First Received:	April 27, 2007
Results First Received:	April 10, 2009
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00467649 History of Changes
Health Authority:	United States: Institutional Review Board