Type 2 Diabetes MellitusPhase 4NCT00467649

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 study testing pramlintide acetate (Symlin), rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) and basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir]) in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: pramlintide acetate (Symlin), rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]) and basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 112 participants
Where: 37 sitesUnited States
Study dates: May 2007to Apr 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Research Site
Aiken, South Carolina
Research Site
Albany, New York
Research Site
Albuquerque, New Mexico
Research Site
Aurora, Colorado
Research Site
Austin, Texas
Research Site
Baltimore, Maryland
Research Site
Bartlett, Tennessee
Research Site
Baton Rouge, Louisiana
Research Site
Bridgeville, Pennsylvania
Research Site
Butte, Montana
Research Site
Dallas, Texas
Research Site
Detroit, Michigan
Research Site
Grand Rapids, Michigan
Research Site
Hamilton, New Jersey
Research Site
Hollywood, Florida
Research Site
Indianapolis, Indiana
Research Site
Jackson, Mississippi
Research Site
Las Vegas, Nevada
Research Site
Lexington, Kentucky
Research Site
Loma Linda, California
Research Site
Maitland, Florida
Research Site
Mentor, Ohio
Research Site
Miami, Florida
Research Site
Nashville, Tennessee
Research Site
North Miami Beach, Florida
Research Site
Northport, Alabama
Research Site
Olympia, Washington
Research Site
Peoria, Illinois
Research Site
Philadelphia, Pennsylvania
Research Site
Phoenix, Arizona
Research Site
Plantation, Florida
Research Site
Portland, Oregon
Research Site
Roswell, Georgia
Research Site
Spokane, Washington
Research Site
St Louis, Missouri
Research Site
Staten Island, New York
Research Site
Wichita, Kansas

Other trials in United States

About this study

Official title: 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

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.

Conditions: Type 2 Diabetes Mellitus
Being tested: pramlintide acetate (Symlin), rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]), basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Keywords: Symlin, Amylin, insulin, Humalog, Novolog, Apidra
Medical subject headings: Diabetes Mellitus, Type 2, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pramlintide acetate (Symlin)Drug
Also called Symlin
subcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals
rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])Drug
subcutaneous injection, dosing based on titration guidelines
basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])Drug
subcutaneous injection, dosing based on titration guidelines

Study groups in NCT00467649
Study group	Role	What they receive
Group A	Experimental	Not described Receives: Drug: pramlintide acetate (Symlin); Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Group B	Active comparator	Not described Receives: Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]); Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

Percentage of Patients Achieving HbA1c <=7% at Week 24
This is a component of the primary endpoint
Measured: 24 Weeks
Percentage of Patients With no Weight Gain at Week 24
This is a component of the primary endpoint
Measured: 24 Weeks
Percentage of Patients With a Severe Hypoglycemia Adverse Event
This is a component of the primary endpoint.
Measured: 24 Weeks
Change in HbA1c From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Measured: From Baseline to Week 24
Change in Body Weight From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Measured: From Baseline to Week 24
Change in Waist Circumference From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Measured: From Baseline to Week 24
Change in Fasting Plasma Glucose From Baseline at Week 24
Baseline values are presented in the Baseline Characteristics section
Measured: From Baseline to Week 24
Fasting Serum Lipids Change From Baseline to Week 24
Measured: Baseline, week 24
Phase 2: Change in HbA1c at Week 36
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).
Measured: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36
Phase 2: Change in Body Weight at Week 36
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).
Measured: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Apr 2008

First posted1 May 2007 (estimated)
Study startMay 2007
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 112 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00467649
Sponsor's protocol ID: ACA401
Status last verified: Mar 2015
First submitted: 27 Apr 2007
Last updated: 14 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Peyrot M, Rubin RR, Polonsky WH, Best JH. Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs. Curr Med Res Opin. 2010 May;26(5):1047-54. doi: 10.1185/03007991003634759.
PubMed 20199136

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00467649
Acronym / sponsor ID: ACA401
Conditions: Type 2 Diabetes Mellitus
Keywords: Symlin, Amylin, insulin, Humalog, Novolog, Apidra
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 112 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 1 May 2007 (estimated)
Results: Posted 4 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: pramlintide acetate (Symlin), Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])
Group B	Active comparator	Drug: rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine]), Drug: basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pramlintide acetate (Symlin)Also: Symlinsubcutaneous injection (60 mcg or 120 mcg), immediately prior to major meals	Drug	Group A
rapid acting insulin (Humalog® [insulin lispro], Novolog® [insulin aspart], or Apidra® [insulin glulisine])subcutaneous injection, dosing based on titration guidelines	Drug	Group B
basal insulin (Lantus® [insulin glargine], or Levemir® [insulin detemir])subcutaneous injection, dosing based on titration guidelines	Drug	Group A, Group B

Primary outcome

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
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.

10 secondary outcomes

Percentage of Patients Achieving HbA1c <=7% at Week 24
Time frame: 24 Weeks
Percentage of Patients With no Weight Gain at Week 24
Time frame: 24 Weeks
Percentage of Patients With a Severe Hypoglycemia Adverse Event
Time frame: 24 Weeks
Change in HbA1c From Baseline at Week 24
Time frame: From Baseline to Week 24
Change in Body Weight From Baseline at Week 24
Time frame: From Baseline to Week 24
Change in Waist Circumference From Baseline at Week 24
Time frame: From Baseline to Week 24
Change in Fasting Plasma Glucose From Baseline at Week 24
Time frame: From Baseline to Week 24
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
Phase 2: Change in Body Weight at Week 36
Time frame: Phase 1 Baseline, Phase 2 Baseline at Week 24, Week 36

Results and safety

Results posted to the registry on 4 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A (Phase 1 SYMLIN)	57	48
Group B (Phase 1 RA Insulin)	56	50
Group C (Phase 2 SYMLIN)	0	0
Group D (Phase 2 SYMLIN+RA)	0	0
Group E (Phase 2 RA Insulin)	0	0
Group F (Phase 2 RA Insulin + SYMLIN)	0	0

Primary outcome: 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. Number. Unit: Percent

Measure	Group A (Phase 1 SYMLIN) n = 56	Group B (Phase 1 RA Insulin) n = 56
Value	30.4	10.7

Group A (Phase 1 SYMLIN) vs Group B (Phase 1 RA Insulin): p = 0.0180, Fisher Exact

Population analysed: Phase 1 Intent-to-Treat LOCF. LOCF: If a treated patient has missing result value at week 24, then last observed value before week 24 and after baseline is carried forward to impute the week 24 value.

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A (Phase 1 SYMLIN)	1 of 56 (1.8%)	29 of 56 (51.8%)	Not reported
Group B (Phase 1 RA Insulin)	5 of 56 (8.9%)	28 of 56 (50%)	Not reported
Group C (Phase 2 SYMLIN)	0 of 17 (0%)	9 of 17 (52.9%)	Not reported
Group D (Phase 2 SYMLIN+RA)	0 of 31 (0%)	11 of 31 (35.5%)	Not reported
Group E (Phase 2 RA Insulin)	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
Group F (Phase 2 RA Insulin + SYMLIN)	0 of 36 (0%)	11 of 36 (30.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20199136Peyrot M, Rubin RR, Polonsky WH, Best JH. Patient reported outcomes in adults with type 2 diabetes on basal insulin randomized to addition of mealtime pramlintide or rapid-acting insulin analogs. Curr Med Res Opin. 2010 May;26(5):1047-54. doi: 10.1185/03007991003634759.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa Porter, MD study director

Amylin Pharmaceuticals, LLC.

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00467649, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.