Diabetes Mellitus, Type 2NCT01377155
A Comparison of Two Initial Dosing Formulas
A study testing Insulin detemir in people with Diabetes Mellitus, Type 2, run by Diabetes Care Center at 1 site in United States.
Trial summary
This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin detemir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Dec 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Age 18 years and above
- Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides
- A1c ≥ 7.0% but ≤ 10%
- Capable of self monitoring glucose ≥4/day
- Previously compliant with clinical recommendations
- Fasting blood glucose ≥ 150 mg/dl
- BMI ≤ 45 kg/m2
Who cannot join
- Urinary ketosis
- Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatinine >1.5 mg/dl), glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistant of another)
- Currently participating in another clinical trial
- Known or suspected allergy to insulin determir
- Using insulin
- Pregnancy or nursing or the intention of becoming pregnant or not using adequate
- Significant liver or heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus
This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.
Read the detailed description
The current recommended starting dose of basal insulin in type 2 diabetes is either a fixed dose, e.g. 10 U, or a weight-based formulas, 0.1-0.2 U/kg. The estimate of eventual titration dose to attempt to reach a fasting glucose goal is 0.49 U/kg. Those many weeks of dosage upward titration are required. The investigators propose to compare the current recommended weight based, 0.1 U/kg to a correction factor derived formula. Starting with an insulin tolerance test estimation of basal dose, one would arrive at the eventual titrated basal insulin dose in significantly less days than starting at a starting dose estimate of 0.1 U/kg. Further, there would be no significant increase in overall reported hypoglycemia.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin detemir
- Keywords
- basal insulin, hypoglycemia, diabetes mellitus type two
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin detemirDrug
Subjects will be randomized to weight based method of 0.1 U/kg for basal insulin or a starting dose based upon an insulin challenge. Subject will record morning fasting blood sugar daily. Using a three day average, the subject will titrate the dose of basal insulin either increasing or lowering by three units based upon target blood glucose of 110 mg/dl.
| Study group | Role | What they receive |
|---|---|---|
| Insulin determir | Other | Not described Receives: Drug: Insulin detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to reach the titration target
The number of days for the subject to reach the titration target blood sugar of 110 ml/dl
Measured: 12 weeks
Secondary outcomes (1)
The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Care Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Allen B. King, MD, Diabetes Care Center
- Investigators
- Allen B King, MD, Principal investigator, Diabetes Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377155
- Sponsor's protocol ID
- DCC 03-11
- Status last verified
- Aug 2013
- First submitted
- 17 Jun 2011
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Initial Dosing Formulas for Basal Insulin in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01377155
- Acronym / sponsor ID
- DCC 03-11
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- basal insulin, hypoglycemia, diabetes mellitus type two
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Diabetes Care CenterIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jun 2011 (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.
This study will evaluate two methods of starting basal insulin to see which method may achieve a faster-to-goal titration.
Detailed description
The current recommended starting dose of basal insulin in type 2 diabetes is either a fixed dose, e.g. 10 U, or a weight-based formulas, 0.1-0.2 U/kg. The estimate of eventual titration dose to attempt to reach a fasting glucose goal is 0.49 U/kg. Those many weeks of dosage upward titration are required. The investigators propose to compare the current recommended weight based, 0.1 U/kg to a correction factor derived formula. Starting with an insulin tolerance test estimation of basal dose, one would arrive at the eventual titrated basal insulin dose in significantly less days than starting at a starting dose estimate of 0.1 U/kg. Further, there would be no significant increase in overall reported hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin determir | Other | Drug: Insulin detemir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes
- Age 18 years and above
- Concurrently on ± sulfonylureas ± thiazolidinedione ± DDP IV inhibitors ± metformin ± glinides
- A1c ≥ 7.0% but ≤ 10%
- Capable of self monitoring glucose ≥4/day
Key exclusion criteria (7 listed)
- Urinary ketosis
- Currently or expected alteration in insulin sensitivity such as major surgery, infection, renal failure (creatinine >1.5 mg/dl), glucocorticoid treatment, recent (within 2 weeks) serious hypoglycaemic episode (requires assistant of another)
- Currently participating in another clinical trial
- Known or suspected allergy to insulin determir
- Using insulin
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 |
|---|---|---|
| Insulin detemirSubjects will be randomized to weight based method of 0.1 U/kg for basal insulin or a starting dose based upon an insulin challenge. Subject will record morning fasting blood sugar daily. Using a three day average, the subject will titrate the dose of basal insulin either increasing or lowering by three units based upon target blood glucose of 110 mg/dl. | Drug | Insulin determir |
Primary outcome
Days to reach the titration target
Time frame: 12 weeks
The number of days for the subject to reach the titration target blood sugar of 110 ml/dl
1 secondary outcome
The frequency of reported and documented (<70 mg/dl) hypoglycemic events per 24 hour period
Time frame: 12 weeks
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 27 Aug 2013.
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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.
Allen B King, MD principal investigator
Diabetes Care Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin detemir in people with Diabetes Mellitus, Type 2, run by Diabetes Care Center 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 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 27 Aug 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Days to reach the titration target (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2013.