Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2008-01-31
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1. Insulatard
Insulatard
Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
2. Detemir
Detemir
Detemir insulin used as long-acting insulin in treatment phase of study.
Interventions
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Insulatard
Insulatard insulin used as long-acting insulin for 16-week treatment phase of study.
Detemir
Detemir insulin used as long-acting insulin in treatment phase of study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Treated with metformin
3. Already on treatment with a long-acting or intermediate insulin.
4. Over 18 years of age,
5. HbA1c \> 7.0%
6. BMI 27-40
7. Able and willing to perform self-blood glucose monitoring.
8. Able and willing to maintain consistent eating habits throughout the entire trial period.
9. Able and willing to maintain consistent physical activity level during the entire trial period
Exclusion Criteria
2. Proliferative retinopathy that has required acute treatment within the last six months.
3. Impaired hepatic or renal functions.
4. Cardiac problems.
5. Uncontrolled hypertension (treated or untreated).
6. Mental incapacity, unwillingness or a language barrier precluding adequate understanding or co-operation.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
University of Surrey
OTHER
Responsible Party
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Principal Investigators
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David Russell-Jones, MB BS
Role: PRINCIPAL_INVESTIGATOR
University of Surrey
Locations
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Cedar Centre, Royal Surrey County Hospital
Guildford, Surrey, United Kingdom
Countries
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References
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Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Other Identifiers
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EC/2008/14/FHMS
Identifier Type: -
Identifier Source: org_study_id
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