Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT00467649Other idACA401

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 112 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: May 2007
Primary completion: Apr 2008
Completion: Apr 2008
First posted: 1 May 2007 (estimated)
Last update posted: 14 Apr 2015 (estimated)
Conditions: Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200720082009

Ph 4
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
NCT00467649
May 2007 to Apr 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This will be a randomized, open label, parallel group, multicenter study. There will be two phases in the study. Phase 1 (Baseline to Week 24) will compare the efficacy and safety of regimens of basal insulin intensified with either Symlin or rapid acting insulin in patients with type 2 diabetes who have either been on a prior regimen of insulin for less than 6 months and were taking less than 50 U total of insulin per day OR are candidates for the initiation of insulin therapy. The purpose of Phase 2 (Week 24 to Week 36) is to explore further intensification of diabetes regimens in patients failing to achieve HbA1c \<=6.5% at Week 24.

Interventions

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])Drug

Arms2

Experimental
Group A
Active comparator
Group B

Primary outcomes1

Outcomes the sponsor listed as 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
Registry description
A severe hypoglycemia is defined as an event during which the patient required the assistance of another individual (including aid in ingestion of oral carbohydrate); and/or required the administration of glucagon injection, intravenous glucose, or other medical intervention.

Secondary outcomes(10)

Percentage of Patients Achieving HbA1c <=7% at Week 24
Time frame · 24 Weeks
Registry description
This is a component of the primary endpoint
Percentage of Patients With no Weight Gain at Week 24
Time frame · 24 Weeks
Registry description
This is a component of the primary endpoint
Percentage of Patients With a Severe Hypoglycemia Adverse Event
Time frame · 24 Weeks
Registry description
This is a component of the primary endpoint.
Change in HbA1c From Baseline at Week 24
Time frame · From Baseline to Week 24
Registry description
Baseline values are presented in the Baseline Characteristics section
Change in Body Weight From Baseline at Week 24
Time frame · From Baseline to Week 24
Registry description
Baseline values are presented in the Baseline Characteristics section
Change in Waist Circumference From Baseline at Week 24
Time frame · From Baseline to Week 24
Registry description
Baseline values are presented in the Baseline Characteristics section
Change in Fasting Plasma Glucose From Baseline at Week 24
Time frame · From Baseline to Week 24
Registry description
Baseline values are presented in the Baseline Characteristics section
Fasting Serum Lipids Change From Baseline to Week 24
Time frame · Baseline, week 24
Phase 2: Change in HbA1c at Week 36
Time frame · Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Registry description
Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).
Phase 2: Change in Body Weight at Week 36
Time frame · Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Registry description
Two changes are calculated, the first by subtracting Week 36 value from the Phase 1 Baseline value (total change over 36 weeks), the second by subtracting the Week 36 value from the Phase 2 Baseline value (change from week 24 to week 36 only).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 24 Weeks

The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia

Group	Value (Percent)
Group A (Phase 1 SYMLIN)	30.4
Group B (Phase 1 RA Insulin)	10.7

Secondary and other outcome results(7)

Secondary outcomeNumber· 24 Weeks

Percentage of Patients Achieving HbA1c <=7% at Week 24

Group	Value (Percent)
Group A (Phase 1 SYMLIN)	44.6
Group B (Phase 1 RA Insulin)	55.4

Secondary outcomeNumber· 24 Weeks

Percentage of Patients With no Weight Gain at Week 24

Group	Value (Percent)
Group A (Phase 1 SYMLIN)	46.4
Group B (Phase 1 RA Insulin)	14.3

Secondary outcomeNumber· 24 Weeks

Percentage of Patients With a Severe Hypoglycemia Adverse Event

Group	Value (Percent)
Group A (Phase 1 SYMLIN)	0.0
Group B (Phase 1 RA Insulin)	0.0

Secondary outcomeLeast squares mean· From Baseline to Week 24

Change in HbA1c From Baseline at Week 24

Group	Value (Percent)	Spread
Group A (Phase 1 SYMLIN)	-1.11	0.17
Group B (Phase 1 RA Insulin)	-1.27	0.17

Secondary outcomeLeast squares mean· From Baseline to Week 24

Change in Body Weight From Baseline at Week 24

Group	Value (kg)	Spread
Group A (Phase 1 SYMLIN)	0.02	0.68
Group B (Phase 1 RA Insulin)	4.65	0.68

Secondary outcomeLeast squares mean· From Baseline to Week 24

Change in Waist Circumference From Baseline at Week 24

Group	Value (cm)	Spread
Group A (Phase 1 SYMLIN)	-0.63	0.87
Group B (Phase 1 RA Insulin)	2.17	0.86

Secondary outcomeMean· From Baseline to Week 24

Change in Fasting Plasma Glucose From Baseline at Week 24

Group	Value (mg/dL)	Spread
Group A (Phase 1 SYMLIN)	-29.0	7.32
Group B (Phase 1 RA Insulin)	-37.8	7.69

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
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	–	1 / 56	29 / 56
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	–	5 / 56	28 / 56
Group C (Phase 2 SYMLIN)Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2	–	0 / 17	9 / 17
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	–	0 / 31	11 / 31
Group E (Phase 2 RA Insulin)Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2	–	0 / 14	4 / 14
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	–	0 / 36	11 / 36

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

15 results

Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs.

Peyrot et al. 2010Current medical research and opinioncited by 21

PMID 20199136DOI 10.1185/03007991003634759PUB-20199136

Full text at the publisher15 results

Publisher page See results (15)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Has a clinical diagnosis of type 2 diabetes mellitus * Has an HbA1c \>7.0% and ≤10.0% * Has a BMI of ≥25 kg/m\^2 and ≤50 kg/m\^2 * Has been on a regimen of insulin for less than 6 months and is taking less than 50 U total of insulin per day, OR has not been on a pre existing insulin regimen and is a candidate for the initiation of basal insulin therapy Exclusion Criteria: * Has experienced recurrent severe hypoglycemia requiring assistance during the past 6 months * Requires the use of drugs that stimulate gastrointestinal motility * Has been previously treated with Symlin (or has participated in a Symlin clinical study) * Is currently being treated with any of the following medications: \*Over-the-counter antiobesity agents (including, but not limited to, herbal supplements) or prescription antiobesity agents (including orlistat \[Xenical®\] and sibutramine \[Meridia®\]); \*Oral, intravenous, or intramuscular systemic steroids by oral or potent inhaled or intrapulmonary steroids that are known to have a high rate of systemic absorption; \*Drugs that directly affect gastrointestinal motility, including but not limited to: dopamine antagonists (e.g., metoclopramide \[Reglan®\]), opiates or anticholinergics; and chronic (more than 10 days within a 6-month period) macrolide antibiotics such as erythromycin and newer derivatives; \*Investigational medications * Has a history or presence of any of the following: \*Eating disorders (including anorexia and/or bulimia); \*Bariatric surgery (gastric bypass, gastric banding, or gastroplasty) * Is currently enrolled in a weight-loss program or plans to enroll in a weight-loss program before termination of the study * Has donated blood within 30 days of study start or plans to donate blood during the duration of the study

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