GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

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

A Phase 4, Randomized, Open Label, Parallel Group, Multicenter Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

Lead sponsor

AstraZeneca

Asset

Pramlintide

Subcutaneous · Amylin analog

Listed sites

Recruiting sites

—

Enrollment

112

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 25-50•HbA1c 7-10%

Primary endpoint

•HbA1c <7.0% achievement (HbA1c <7.0% achievement, Body weight, absolute change (kg), Severe hypoglycemia)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00467649

Org study IDACA401

Timeline

Milestones

Study first posted2007-05-01estimated

Results first posted2009-06-04estimated

Last update posted2015-04-14estimated

Study start2007-05 (month precision)

Primary completion2008-04actual (month precision)

Study completion2008-04actual (month precision)

Assets

Investigational agents

Pramlintide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Percentage of Patients With no Weight Gain at Week 24

Time frame:24 Weeks

threshold achievement, improvement

Posted result

Group	Value (number), Percent	95% CI
Group A (Phase 1 SYMLIN)	46.4	—
Group B (Phase 1 RA Insulin)	14.3	—

Secondary/protocol endpoint

Change in Body Weight From Baseline at Week 24

Time frame:From Baseline to Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), kg	95% CI
Group A (Phase 1 SYMLIN)	0.02	—
Group B (Phase 1 RA Insulin)	4.65	—

Secondary/protocol endpoint

Change in Waist Circumference From Baseline at Week 24

Time frame:From Baseline to Week 24

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), cm	95% CI
Group A (Phase 1 SYMLIN)	-0.63	—
Group B (Phase 1 RA Insulin)	2.17	—

Secondary/protocol endpoint

Phase 2: Change in Body Weight at Week 36

Time frame:Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kg	95% CI
Group C (Phase 2 SYMLIN)Phase 1 Baseline	109.98	—
Change From Phase 1 Baseline to Week 36	-0.80	—
Phase 2 Baseline at Week 24	108.50	—
Change From Phase 2 Baseline to Week 36	0.69	—
Group D (Phase 2 SYMLIN+RA)Phase 1 Baseline	104.83	—
Change From Phase 1 Baseline to Week 36	1.34	—
Phase 2 Baseline at Week 24	105.67	—
Change From Phase 2 Baseline to Week 36	0.50	—
Group E (Phase 2 RA Insulin)Phase 1 Baseline	104.42	—
Change From Phase 1 Baseline to Week 36	3.90	—
Phase 2 Baseline at Week 24	107.87	—
Change From Phase 2 Baseline to Week 36	0.44	—
Group F (Phase 2 RA Insulin + SYMLIN)Phase 1 Baseline	105.30	—
Change From Phase 1 Baseline to Week 36	4.51	—
Phase 2 Baseline at Week 24	110.68	—
Change From Phase 2 Baseline to Week 36	-0.86	—

Glycemic / diabetes

5 endpoints

Primary/protocol endpoint

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

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Severe hypoglycemia

Posted result

Group	Value (number), Percent	95% CI
Group A (Phase 1 SYMLIN)	30.4	—
Group B (Phase 1 RA Insulin)	10.7	—

p0.0180Fisher Exact

Secondary/protocol endpoint

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

Time frame:24 Weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percent	95% CI
Group A (Phase 1 SYMLIN)	44.6	—
Group B (Phase 1 RA Insulin)	55.4	—

Secondary/protocol endpoint

Change in HbA1c From Baseline at Week 24

Time frame:From Baseline to Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percent	95% CI
Group A (Phase 1 SYMLIN)	-1.11	—
Group B (Phase 1 RA Insulin)	-1.27	—

Secondary/protocol endpoint

Change in Fasting Plasma Glucose From Baseline at Week 24

Time frame:From Baseline to Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), mg/dL	95% CI
Group A (Phase 1 SYMLIN)	-29.0	—
Group B (Phase 1 RA Insulin)	-37.8	—

Secondary/protocol endpoint

Phase 2: Change in HbA1c at Week 36

Time frame:Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percent	95% CI
Group C (Phase 2 SYMLIN)Phase 1 Baseline	8.35	—
Change From Phase 1 Baseline to Week 36	-1.96	—
Phase 2 Baseline at Week 24	6.26	—
Change From Phase 2 Baseline to Week 36	0.14	—
Group D (Phase 2 SYMLIN+RA)Phase 1 Baseline	8.03	—
Change From Phase 1 Baseline to Week 36	-0.68	—
Phase 2 Baseline at Week 24	7.57	—
Change From Phase 2 Baseline to Week 36	-0.23	—
Group E (Phase 2 RA Insulin)Phase 1 Baseline	7.85	—
Change From Phase 1 Baseline to Week 36	-1.49	—
Phase 2 Baseline at Week 24	6.14	—
Change From Phase 2 Baseline to Week 36	0.22	—
Group F (Phase 2 RA Insulin + SYMLIN)Phase 1 Baseline	8.38	—
Change From Phase 1 Baseline to Week 36	-0.99	—
Phase 2 Baseline at Week 24	7.32	—
Change From Phase 2 Baseline to Week 36	0.07	—

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Fasting Serum Lipids Change From Baseline to Week 24

Time frame:Baseline, week 24

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Group A (Phase 1 SYMLIN)Total Cholesterol	-1.81	—
HDL	1.11	—
LDL	2.36	—
Triglycerides	-28.96	—
Group B (Phase 1 RA Insulin)Total Cholesterol	5.27	—
HDL	1.65	—
LDL	9.12	—
Triglycerides	-31.98	—

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Percentage of Patients With a Severe Hypoglycemia Adverse Event

Time frame:24 Weeks

Severe hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), Percent	95% CI
Group A (Phase 1 SYMLIN)	0.0	—
Group B (Phase 1 RA Insulin)	0.0	—

Other/protocol endpoint

Hypoglycemia Adverse Events

Time frame:36 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), participants	95% CI
Group A (Phase 1 SYMLIN)Mild	31	—
Moderate	12	—
Severe	0	—
Group B (Phase 1 RA Insulin)Mild	46	—
Moderate	13	—
Severe	0	—
Group C (Phase 2 SYMLIN)Mild	7	—
Moderate	0	—
Severe	0	—
Group D (Phase 2 SYMLIN+RA)Mild	18	—
Moderate	1	—
Severe	0	—
Group E (Phase 2 RA Insulin)Mild	9	—
Moderate	2	—
Severe	0	—
Group F (Phase 2 RA Insulin + SYMLIN)Mild	19	—
Moderate	3	—
Severe	0	—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs.
Current medical research and opinion2010 May (month)PMID20199136doi:10.1185/03007991003634759via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.