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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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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