Type 2 DiabetesPhase 4NCT00998335
Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) on Insulin Secretion and Action in Type 2 Diabetes
A Phase 4 study testing Long-acting bedtime insulin detemir (Levemir) and Insulin detemir and pre-meal insulin aspart. in people with Type 2 Diabetes, run by University of Florida at 1 site in United States.
Trial summary
The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty liver disease (NAFLD) has not been systematically studied before, and in particular, never when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Long-acting bedtime insulin detemir (Levemir) and Insulin detemir and pre-meal insulin aspart.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate patients must:
- Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
- Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
- Age range of 18 to 70 years (inclusive).
- Patients must have been on a stable dose of allowed chronic medications for two months prior to entering the double-blind treatment period.
- All participants must have the following laboratory values:
Show all 11Show fewer
- Hemoglobin ≥ 12 g/dl in males or ≥ 11 g/dl in females
- Serum creatinine ≤ 1.5 mg/dl
- AST (SGOT) ≤ 2.5 times upper limit of normal
- ALT (SGPT) ≤ 2.5 times upper limit of normal
- Alkaline phosphatase ≤ 2.5 times upper limit of normal
Who cannot join
- Patients will be excluded if any of the following criteria are present:
- Individuals with type 1 diabetes or type 2 diabetes and a FPG ≥ 300 mg/dl.
- Subjects on sulfonylureas, metformin and/or TZDs unless the dose has been stable for at least 2 months prior to study entry.
- Patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. Patients taking systemic glucocorticoids will be excluded.
- Past (within 1 year) or current history of alcohol abuse.
- Patients will be excluded if there is a history of clinically significant heart disease (New York Heart Classification greater than grade II), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas H.S.C. at San Antonio and the San Antonio Audie L. Murphy VA Hospital
San Antonio, Texas, 78229-3900
About this study
Official title: Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) to Improve Insulin Secretion and Action in Subjects With Type 2 Diabetes
The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty liver disease (NAFLD) has not been systematically studied before, and in particular, never when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). This study is to determine the effect on hepatic steatosis and insulin secretion/action of lowering the fasting plasma glucose (FPG) to target with once daily basal insulin detemir alone or combining insulin detemir with premeal insulin aspart in patients with uncontrolled type 2 diabetes mellitus (T2DM).
In the first 3 months the investigators will optimize metabolic control in all patients with intensive basal (bedtime) detemir insulin aiming at a normal fasting plasma glucose. After this treatment period, patients will be randomized in the second 3 months in a 2:1 ratio to insulin detemir or detemir plus aspart. The investigators propose that insulin will improve day-long glycemic control and A1c, reduce hepatic steatosis (NAFLD) (primary endpoint) and insulin secretion/sensitivity being well tolerated while causing minimal weight gain and hypoglycemia (secondary endpoints). The study will allow to assess if there is an additional benefit of adding pre-meal rapid-acting insulin aspart to basal insulin to these endpoints.
Read the detailed description
The control of hyperglycemia in T2DM ameliorates the metabolic abnormalities of T2DM but whether this improves hepatic steatosis has not been examined carefully with the use of improved insulin formulations (long-acting insulins detemir or glargine, alone or combined with pre-meal short-acting insulins). Most research studies have focused on glycemic control without a careful examination to the underlying mechanisms, with some of these studies reporting on improved hepatic and muscle insulin sensitivity. The investigators have found in the laboratory that intensified insulin therapy in T2DM is associated with enhanced glycogen synthase fractional velocity and non-oxidative glucose disposal, but with no improvement at the level of insulin-stimulated insulin receptor tyrosine phosphorylation, hexokinase II mRNA or enzyme function, phosphatidylinositol 3-kinase (PI 3-kinase) associated with IRS-1, or Akt phosphorylation. Our work did not examine hepatic steatosis or insulin secretion/action, nor was designed to distinguish between the relative contribution of reduced glucotoxicity on insulin sensitivity vs. beta-cell function from pre-meal regular vs. NPH insulin. It is possible that the beneficial effects of insulin therapy of reduced plasma glucose and FFA concentrations may be offset by excessive hyperinsulinemia and weight gain from the use of insulins with suboptimal pharmacokinetics compared to the newer insulin formulations.
Insulin detemir is an insulin analogue approved in 2005 by the FDA. It is a long-acting insulin analogue that has shown to be more predictable in achieving therapeutic plasma insulin levels compared to NPH insulin. This is associated with several clinical benefits, such as better glycemic control, less hypoglycemia, modest weight gain and better quality of life for patients with type 2 diabetes. If gluco-lipotoxicity likely play an important role in the development of hepatic steatosis (NAFLD) in T2DM the investigators speculate that if reversed by a strategy of basal long-acting insulin (insulin detemir) alone, or combined with a rapid-acting analog (pre-meal insulin aspart) may be a good strategy for the treatment of T2DM.
- Conditions
- Type 2 Diabetes
- Being tested
- Long-acting bedtime insulin detemir (Levemir), Insulin detemir and pre-meal insulin aspart.
- Keywords
- Type 2 diabetes mellitus, Insulin therapy, Detemir (Levemir), Aspart (Novolog), Hepatic steatosis
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-acting bedtime insulin detemir (Levemir)Drug
Also called Levemir insulin (trademark insulin by Novo Nordisk)
This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
Insulin detemir and pre-meal insulin aspart.Drug
Also called Insulin detemir = Levemir (Novo Nordisk), Insulin aspart = Novolog (Novo Nordisk)
This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner.
| Study group | Role | What they receive |
|---|---|---|
| Insulin detemir only | Active comparator | Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir). Receives: Drug: Long-acting bedtime insulin detemir (Levemir) |
| Insulin detemir plus aspart | Experimental | After baseline evaluations, insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart (insulin detemir plus aspart) will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated. This group will receive Insulin detemir and pre-meal insulin aspart. Receives: Drug: Insulin detemir and pre-meal insulin aspart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic Steatosis
Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).
Measured: 3 and 6 months
Secondary outcomes (11)
Metabolic Control as Measured by the A1c
Measured: 3 and 6 months
Change in Insulin Secretion
Derived from the hyperglycemic clamp (Plasma C-peptide change vs. pretreatment in first and second phase).
Measured: 3 and 6 months.
Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).
Percent intramyocellular (IMCL) by magnetic resonance imaging and spectroscopy (MRS).
Measured: 3 and 6 months.
Plasma Lipid Concentration.
Fasting plasma lipid concentration on day of admission at 3 and 6 months.
Measured: 3 and 6 months.
Change in Anthropometric Measure (Body Weight).
Change in anthropometric measure (body weight) done on day of admission at 3 and 6 months.
Measured: 3 and 6 months.
Number of Hypoglycemic Events
Defined as hypoglycemia <40 mg/dl and/or requiring medical assistance during the trial.
Measured: 3 and 6 months
Metabolic Control as Measured by the Fasting Plasma Glucose Concentration
Measured: 3 and 6 months
Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.
Measured: 3 and 6 months
Advanced Lipid Testing
Change in lipoprotein particle number was determined using NMR.
Measured: 3 and 6 months
Change in Anthropometric Measure (Body Mass Index [BMI]).
Change in anthropometric measure (body mass index [BMI]) done on day of admission at 3 and 6 months.
Measured: 3 and 6 months.
Percent Change From Baseline in Vascular Inflammatory Markers
Inflammatory Markers include: Adiponectin, MMP-9, E-selectin, sICAM, and sVCAM
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJun 2007
- Primary completionFeb 2010
- Study completionFeb 2010
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.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development, Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Kenneth Cusi, M.D., Principal investigator, University of Flordia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998335
- Sponsor's protocol ID
- 20060167
- Status last verified
- Jun 2016
- First submitted
- 19 Oct 2009
- Last updated
- 28 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Basal/Pre-Meal Insulin Strategy (Detemir/Aspart) to Improve Insulin Secretion and Action in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00998335
- Acronym / sponsor ID
- 20060167
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes mellitus, Insulin therapy, Detemir (Levemir), Aspart (Novolog), Hepatic steatosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- VA Office of Research and Development, Novo Nordisk A/S
- Study start
- Jun 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Posted 29 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty liver disease (NAFLD) has not been systematically studied before, and in particular, never when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). This study is to determine the effect on hepatic steatosis and insulin secretion/action of lowering the fasting plasma glucose (FPG) to target with once daily basal insulin detemir alone or combining insulin detemir with premeal insulin aspart in patients with uncontrolled type 2 diabetes mellitus (T2DM).
In the first 3 months the investigators will optimize metabolic control in all patients with intensive basal (bedtime) detemir insulin aiming at a normal fasting plasma glucose. After this treatment period, patients will be randomized in the second 3 months in a 2:1 ratio to insulin detemir or detemir plus aspart. The investigators propose that insulin will improve day-long glycemic control and A1c, reduce hepatic steatosis (NAFLD) (primary endpoint) and insulin secretion/sensitivity being well tolerated while causing minimal weight gain and hypoglycemia (secondary endpoints). The study will allow to assess if there is an additional benefit of adding pre-meal rapid-acting insulin aspart to basal insulin to these endpoints.
Detailed description
The control of hyperglycemia in T2DM ameliorates the metabolic abnormalities of T2DM but whether this improves hepatic steatosis has not been examined carefully with the use of improved insulin formulations (long-acting insulins detemir or glargine, alone or combined with pre-meal short-acting insulins). Most research studies have focused on glycemic control without a careful examination to the underlying mechanisms, with some of these studies reporting on improved hepatic and muscle insulin sensitivity. The investigators have found in the laboratory that intensified insulin therapy in T2DM is associated with enhanced glycogen synthase fractional velocity and non-oxidative glucose disposal, but with no improvement at the level of insulin-stimulated insulin receptor tyrosine phosphorylation, hexokinase II mRNA or enzyme function, phosphatidylinositol 3-kinase (PI 3-kinase) associated with IRS-1, or Akt phosphorylation. Our work did not examine hepatic steatosis or insulin secretion/action, nor was designed to distinguish between the relative contribution of reduced glucotoxicity on insulin sensitivity vs. beta-cell function from pre-meal regular vs. NPH insulin. It is possible that the beneficial effects of insulin therapy of reduced plasma glucose and FFA concentrations may be offset by excessive hyperinsulinemia and weight gain from the use of insulins with suboptimal pharmacokinetics compared to the newer insulin formulations.
Insulin detemir is an insulin analogue approved in 2005 by the FDA. It is a long-acting insulin analogue that has shown to be more predictable in achieving therapeutic plasma insulin levels compared to NPH insulin. This is associated with several clinical benefits, such as better glycemic control, less hypoglycemia, modest weight gain and better quality of life for patients with type 2 diabetes. If gluco-lipotoxicity likely play an important role in the development of hepatic steatosis (NAFLD) in T2DM the investigators speculate that if reversed by a strategy of basal long-acting insulin (insulin detemir) alone, or combined with a rapid-acting analog (pre-meal insulin aspart) may be a good strategy for the treatment of T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin detemir only | Active comparator | Drug: Long-acting bedtime insulin detemir (Levemir)Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir). |
| Insulin detemir plus aspart | Experimental | Drug: Insulin detemir and pre-meal insulin aspart.After baseline evaluations, insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart (insulin detemir plus aspart) will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated. This group will receive Insulin detemir and pre-meal insulin aspart. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
- Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
- Age range of 18 to 70 years (inclusive).
- Patients must have been on a stable dose of allowed chronic medications for two months prior to entering the double-blind treatment period.
- All participants must have the following laboratory values:
Key exclusion criteria (6 listed)
- Individuals with type 1 diabetes or type 2 diabetes and a FPG ≥ 300 mg/dl.
- Subjects on sulfonylureas, metformin and/or TZDs unless the dose has been stable for at least 2 months prior to study entry.
- Patients on any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable doses of such agents for the past two months before entry into the study. Patients may be taking stable doses of estrogens or other hormonal replacement therapy if the patient has been on these agents for the prior two months. Patients taking systemic glucocorticoids will be excluded.
- Past (within 1 year) or current history of alcohol abuse.
- Patients will be excluded if there is a history of clinically significant heart disease (New York Heart Classification greater than grade II), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) or chronic renal failure (serum creatinine greater than 1.5 mg/dl).
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 |
|---|---|---|
| Long-acting bedtime insulin detemir (Levemir)Also: Levemir insulin (trademark insulin by Novo Nordisk)This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. | Drug | Insulin detemir only |
| Insulin detemir and pre-meal insulin aspart.Also: Insulin detemir = Levemir (Novo Nordisk), Insulin aspart = Novolog (Novo Nordisk)This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner. | Drug | Insulin detemir plus aspart |
Primary outcome
Hepatic Steatosis
Time frame: 3 and 6 months
Hepatic steatosis measured by proton magnetic resonance spectroscopy (1H-MRS).
11 secondary outcomes
Metabolic Control as Measured by the A1c
Time frame: 3 and 6 months
Change in Insulin Secretion
Time frame: 3 and 6 months.
Intramyocellular (IMCL) by Magnetic Resonance Imaging and Spectroscopy (MRS).
Time frame: 3 and 6 months.
Plasma Lipid Concentration.
Time frame: 3 and 6 months.
Change in Anthropometric Measure (Body Weight).
Time frame: 3 and 6 months.
Number of Hypoglycemic Events
Time frame: 3 and 6 months
Metabolic Control as Measured by the Fasting Plasma Glucose Concentration
Time frame: 3 and 6 months
Metabolic Control as Measured by the Postprandial Plasma Glucose During the Day-long Plasma Glucose Profile.
Time frame: 3 and 6 months
Advanced Lipid Testing
Time frame: 3 and 6 months
Change in Anthropometric Measure (Body Mass Index [BMI]).
Time frame: 3 and 6 months.
Percent Change From Baseline in Vascular Inflammatory Markers
Time frame: 3 and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kenneth Cusi, M.D. principal investigator
University of Flordia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long-acting bedtime insulin detemir (Levemir) and Insulin detemir and pre-meal insulin aspart. in people with Type 2 Diabetes, run by University of Florida 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 11 inclusion and 6 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 28 Sep 2016. 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.
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 29 Jul 2016). 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?
Hepatic Steatosis (time frame: 3 and 6 months). 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 28 Sep 2016.