DiabetesPhase 4TITRATE™NCT00634842

Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily

A Phase 4 study testing insulin detemir in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 69 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin detemir
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 244 participants
Where: 69 sitesin 2 countries
Study dates: Feb 2008to Oct 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes
1-3 oral treatments
Insulin naive
BMI (Body Mass Index) less than or equal to 45

Who cannot join

Pregnancy
Retinopathy
Cardiac disease
Uncontrolled hypertension
Recurrent hypoglycaemia

Trial locations and contacts

69 sites in 2 countries.

Country

City, postcode or hospital

69 sites in 2 countries

United States66 sites

Novo Nordisk Investigational Site
Altoona, Pennsylvania, 16602
Novo Nordisk Investigational Site
Arlington, Texas, 76014
Novo Nordisk Investigational Site
Artesia, California, 90701
Novo Nordisk Investigational Site
Athens, Georgia, 30606
Novo Nordisk Investigational Site
Berlin, New Jersey, 08009
Novo Nordisk Investigational Site
Boca Raton, Florida, 33433
Novo Nordisk Investigational Site
Camden, New Jersey, 08104
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017-3632
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
Clearwater, Florida, 33755-2138
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75390-9302
Novo Nordisk Investigational Site
Dayton, Ohio, 45406
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Fullerton, California, 92835-3404
Novo Nordisk Investigational Site
Goodyear, Arizona, 85395
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Houston, Texas, 77025
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Jacksonville, Florida, 32205
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Lake Mary, Florida, 32746
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89101
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Los Angeles, California, 90036
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Mentor, Ohio, 44060
Novo Nordisk Investigational Site
Midland, Texas, 79707
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70121
Novo Nordisk Investigational Site
New York, New York, 10023
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Norwalk, Connecticut, 06851
Novo Nordisk Investigational Site
Odessa, Texas, 79761
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73103
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Orange, California, 92869
Novo Nordisk Investigational Site
Parker, Colorado, 80138-8789
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Pikesville, Maryland, 21208-3737
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Prospect, Connecticut, 06712
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Saint Paul, Minnesota, 55108
Novo Nordisk Investigational Site
San Antonio, Texas, 78209
Novo Nordisk Investigational Site
Savannah, Georgia, 31406
Novo Nordisk Investigational Site
Scottsdale, Arizona, 85251-5638
Novo Nordisk Investigational Site
Searcy, Arkansas, 72143
Novo Nordisk Investigational Site
Shelby, North Carolina, 28152
Novo Nordisk Investigational Site
Spartanburg, South Carolina, 29303
Novo Nordisk Investigational Site
Spokane, Washington, 99204-2629
Novo Nordisk Investigational Site
Spokane, Washington, 99218
Novo Nordisk Investigational Site
Spring Valley, California, 91978
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Statesville, North Carolina, 28625
Novo Nordisk Investigational Site
Taylors, South Carolina, 29687
Novo Nordisk Investigational Site
Terre Haute, Indiana, 47802
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
West Seneca, New York, 14224

Other trials in United States

Puerto Rico3 sites

Novo Nordisk Investigational Site
Caguas, 00725
Novo Nordisk Investigational Site
San Juan, 00921
Novo Nordisk Investigational Site
Trujillo Alto, 00976

Other trials in Puerto Rico

About this study

Official title: Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin detemir
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

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

insulin detemirDrug
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL
insulin detemirDrug
Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL

Study groups in NCT00634842
Study group	Role	What they receive
FPG 70-90 mg/dL	Experimental	Aggressive FPG (fasting plasma glucose) titration target range group Receives: Drug: insulin detemir
FPG 80-110 mg/dL	Experimental	Conventional FPG (fasting plasma glucose) titration target range group Receives: Drug: insulin detemir

What is being measured

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

Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment
Measured: week 20

Secondary outcomes (3)

Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment
Measured: week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20
Measured: week -2, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:
- If subject was unable to treat himself: Major incidence.
- If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.
- If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.
Measured: weeks 0-20

Timeline

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

Feb 2008Oct 2008

First posted13 Mar 2008 (estimated)
Study startFeb 2008
Primary completionOct 2008
Study completionOct 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 DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe 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: 244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00634842
Sponsor's protocol ID: NN304-3502
Acronym: TITRATE™
Status last verified: Jan 2017
First submitted: 6 Mar 2008
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.
PubMed 19515182

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?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents
ClinicalTrials.gov ID: NCT00634842
Acronym / sponsor ID: TITRATE™ / NN304-3502
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 244 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 13 Mar 2008 (estimated)
Results: Posted 22 Dec 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
FPG 70-90 mg/dL	Experimental	Drug: insulin detemirAggressive FPG (fasting plasma glucose) titration target range group
FPG 80-110 mg/dL	Experimental	Drug: insulin detemirConventional FPG (fasting plasma glucose) titration target range group

Who may qualify

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

Key inclusion criteria (4 listed)

Type 2 diabetes
1-3 oral treatments
Insulin naive
BMI (Body Mass Index) less than or equal to 45

Key exclusion criteria (5 listed)

Pregnancy
Retinopathy
Cardiac disease
Uncontrolled hypertension
Recurrent hypoglycaemia

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 detemirTreat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL	Drug	FPG 70-90 mg/dL
insulin detemirTreat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 80-110 mg/dL	Drug	FPG 80-110 mg/dL

Primary outcome

Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%
Time frame: week 20
Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment

3 secondary outcomes

Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%
Time frame: week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline
Time frame: week -2, week 20
Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)
Time frame: weeks 0-20

Results and safety

Results posted to the registry on 22 Dec 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
FPG 70-90 mg/dL	122	107
FPG 80-110 mg/dL	122	104

Primary outcome: Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%

Time frame: week 20. Number. Unit: percentage of participants

Measure	FPG 70-90 mg/dL n = 112	FPG 80-110 mg/dL n = 112
Value	64.3	54.5

FPG 70-90 mg/dL vs FPG 80-110 mg/dL: Odds Ratio (OR): 1.86 (95% CI 1.03 to 3.37), p = 0.0411, Test for Difference in Proportions

Population analysed: The intent-to-treat (ITT) population with non-missing HbA1c values at end of study, LOCF (last observation carried forward)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected in a time span of 20 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FPG 70-90 mg/dL	5 of 121 (4.1%)	45 of 121 (37.2%)	Not reported
FPG 80-110 mg/dL	4 of 122 (3.3%)	30 of 122 (24.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19515182Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.
Clinical Trials at Novo NordiskLink provided by the sponsor.

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

69 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin detemir in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 69 sites in 2 countries.

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 5 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Puerto Rico. 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 22 Dec 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?

Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7% (time frame: week 20). 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 NCT00634842, 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 10 Mar 2017.