Type 1 DiabetesPhase 1NCT01708044
Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM
A Phase 1 study testing Pramlintide acetate in people with Type 1 Diabetes, run by AstraZeneca at 1 site in United States.
Trial summary
To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with type 1 diabetes on postprandial plasma glucose concentrations Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Pramlintide acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 18 to 70 years old
- Is male, or is female and meets all the following criteria:
- Not breastfeeding
- Negative pregnancy test result and, if of childbearing potential, must practice and be willing to continue to practice appropriate birth control
- Has been diagnosed with type 1 diabetes mellitus for at least 1 year and not achieving glycemic goal while on MDI of insulin
- Has HbA1c between 7.0% and 9.0%
- Has been on MDI of regular insulin, at a dose not to exceed 10 units/breakfast for at least 3 months or has been on continuous subcutaneous insulin infusion (CSII), at a dose not to exceed 10 units/breakfast, for at least 3 months and is willing to switch to an MDI insulin regimen for 1 day prior to enrollment and through the study
- Has a body mass index (BMI) <30 kg/m2
Who cannot join
- Has experienced recurrent severe hypoglycemia requiring assistance within 6 months before Visit 1 Screening
- Has a history of hypoglycemia unawareness
- Has a confirmed diagnosis of gastroparesis
- Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications:
- Any antihyperglycemic agent other than insulin
- Drugs that directly affect gastrointestinal motility (e.g., anticholinergic agents such as atropine)
Show all 22Show fewer
- Drugs that slow the intestinal absorption of nutrients (e.g., α-glucosidase inhibitors.
- Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
- Hepatic disease
- Renal disease
- Gastrointestinal disease
- Pulmonary disease
- Organ transplantation
- Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus)
- Is currently treated or has been previously treated with SYMLIN/pramlintide or has participated in a SYMLIN/pramlintide clinical study within 3 months of Visit 1 (Screening).
- Has any clinically significant laboratory findings or medical history that may affect successful completion of the study and/or personal well-being
- Has donated blood within 2 months or is planning to donate blood during the study.
- Has had a major surgery or a blood transfusion within 2 months
- Has received any investigational drug within 1 month
- Has known allergies or hypersensitivity to any component of study treatment.
- Is an immediate family member of personnel directly affiliated with the study at the clinical study site, or is directly affiliated with the study at the clinical study site.
- Is employed by Amylin Pharmaceuticals, Inc (Amylin) (that is an employee, temporary contract worker, or designee responsible for the conduct of the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control in Subjects With Type 1 Diabetes Mellitus
To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with type 1 diabetes on postprandial plasma glucose concentrations
- Conditions
- Type 1 Diabetes
- Being tested
- Pramlintide acetate, Placebo
- Keywords
- Pramlintide,, insulin,, type 1 diabetes,, reduction in postprandial glucose,, pramlintide:insulin dose-ratio
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramlintide acetateDrug
PlaceboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Pramlintide 6 mcg per unit of insulin dose | Experimental | The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 6 mcg for each unit of insulin. Receives: Drug: Pramlintide acetate |
| Pramlintide 9 mcg per unit of insulin dose | Experimental | The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 9 mcg for each unit of insulin. Receives: Drug: Pramlintide acetate |
| Pramlintide 12 mcg per unit of insulin dose | Experimental | The pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 12 mcg for each unit of insulin. Receives: Drug: Pramlintide acetate |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment
Measured: AUC 0-3 hrs compared to Placebo
Secondary outcomes (4)
Incremental AUC (0-3 h) of plasma glucagon
Measured: 0-3 hrs compared to Placebo
Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.
Measured: 0-3 hrs compared to Placebo
PK of pramlintide
Measured: 0-3 hrs compared to Placebo
Safety
Measured: 0-3 hrs compared to Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708044
- Sponsor's protocol ID
- D5570C00001
- Status last verified
- Oct 2014
- First submitted
- 12 Oct 2012
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Riddle MC, Yuen KC, de Bruin TW, Herrmann K, Xu J, Ohman P, Kolterman OG. Fixed ratio dosing of pramlintide with regular insulin before a standard meal in patients with type 1 diabetes. Diabetes Obes Metab. 2015 Sep;17(9):904-7. doi: 10.1111/dom.12504. Epub 2015 Jul 8.
PubMed 26040429
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled Single-Blind, Dose-Ranging, 4-Way Crossover Study to Evaluate the Effect of Different Fixed Pramlintide: Insulin Dose Ratios on Postprandial Glycemic Control in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01708044
- Acronym / sponsor ID
- D5570C00001
- Conditions
- Type 1 Diabetes
- Keywords
- Pramlintide,, insulin,, type 1 diabetes,, reduction in postprandial glucose,, pramlintide:insulin dose-ratio
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the effects of different fixed pramlintide:insulin dose ratios in subjects with type 1 diabetes on postprandial plasma glucose concentrations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pramlintide 6 mcg per unit of insulin dose | Experimental | Drug: Pramlintide acetateThe pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 6 mcg for each unit of insulin. |
| Pramlintide 9 mcg per unit of insulin dose | Experimental | Drug: Pramlintide acetateThe pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 9 mcg for each unit of insulin. |
| Pramlintide 12 mcg per unit of insulin dose | Experimental | Drug: Pramlintide acetateThe pramlintide dose will be calculated based on the subjects' individual insulin units. Dose ratio to be examined is pramlintide 12 mcg for each unit of insulin. |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is 18 to 70 years old
- Is male, or is female and meets all the following criteria:
- Has been diagnosed with type 1 diabetes mellitus for at least 1 year and not achieving glycemic goal while on MDI of insulin
- Has HbA1c between 7.0% and 9.0%
- Has been on MDI of regular insulin, at a dose not to exceed 10 units/breakfast for at least 3 months or has been on continuous subcutaneous insulin infusion (CSII), at a dose not to exceed 10 units/breakfast, for at least 3 months and is willing to switch to an MDI insulin regimen for 1 day prior to enrollment and through the study
Key exclusion criteria (22 listed)
- Has experienced recurrent severe hypoglycemia requiring assistance within 6 months before Visit 1 Screening
- Has a history of hypoglycemia unawareness
- Has a confirmed diagnosis of gastroparesis
- Has been treated, is currently being treated, or is expected to require or undergo treatment with the following medications:
- Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
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 | Drug | Pramlintide 12 mcg per unit of insulin dose, Pramlintide 6 mcg per unit of insulin dose, Pramlintide 9 mcg per unit of insulin dose |
| PlaceboPlacebo Comparator | Other | Placebo |
Primary outcome
Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment
Time frame: AUC 0-3 hrs compared to Placebo
4 secondary outcomes
Incremental AUC (0-3 h) of plasma glucagon
Time frame: 0-3 hrs compared to Placebo
Absolute AUC (0-3 h), peak plasma concentration (Cmax), Cave, and Tmax of glucagon of plasma glucose.
Time frame: 0-3 hrs compared to Placebo
PK of pramlintide
Time frame: 0-3 hrs compared to Placebo
Safety
Time frame: 0-3 hrs compared to Placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Derived from this study: PubMed 26040429Riddle MC, Yuen KC, de Bruin TW, Herrmann K, Xu J, Ohman P, Kolterman OG. Fixed ratio dosing of pramlintide with regular insulin before a standard meal in patients with type 1 diabetes. Diabetes Obes Metab. 2015 Sep;17(9):904-7. doi: 10.1111/dom.12504. Epub 2015 Jul 8.
- ABA163\_D5570C0001\_CSR SynopsisLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pramlintide acetate in people with Type 1 Diabetes, run by AstraZeneca at 1 site in United States.
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 8 inclusion and 22 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incremental area under the concentration-time curve (AUC(0-3 h)) of plasma glucose concentrations for each treatment (time frame: AUC 0-3 hrs compared to Placebo). 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 NCT01708044, 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 20 Oct 2014.