Effect of Two Different Fasting Blood Glucose Targets on... | NCT00634842

NCT00634842

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FPG 70-90 mg/dL	Experimental	Aggressive FPG (fasting plasma glucose) titration target range group	Drug: insulin detemir
FPG 80-110 mg/dL	Experimental	Conventional FPG (fasting plasma glucose) titration target range group	Drug: insulin detemir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL	FPG 70-90 mg/dL

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	week 20

Secondary Outcomes

Measure	Description	Time Frame
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	week 20
Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Goodyear	Arizona	85395	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19515182	Result	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.

Label	URL
Clinical Trials at Novo Nordisk	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	FPG 70-90 mg/dL	Aggressive FPG (fasting plasma glucose) titration target range group
FG001	FPG 80-110 mg/dL	Conventional FPG (fasting plasma glucose) titration target range group

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	FPG 70-90 mg/dL	Aggressive FPG (fasting plasma glucose) titration target range group
BG001	FPG 80-110 mg/dL	Conventional FPG (fasting plasma glucose) titration target range group
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00056.6± 9.4 BG00157.2± 10.6 BG00256.9± 10.0

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00054 BG00144 BG002

Fasting plasma glucose (FPG)

Level of fasting plasma glucose (FPG) measured at baseline

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000164.0± 43.1 BG001163.1± 40.4

Glycosylated haemoglobin (HbA1c)

Level of glycosylated haemoglobin (HbA1c) measured at baseline

Mean

Standard Deviation

percentage

Title

Denominators

Categories

Title	Measurements
	BG0008.0± 0.6 BG0017.9± 0.6

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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

Posted

Number

percentage of participants

week 20

ID	Title	Description
OG000	FPG 70-90 mg/dL	Aggressive FPG (fasting plasma glucose) titration target range group
OG001	FPG 80-110 mg/dL	Conventional FPG (fasting plasma glucose) titration target range group

Units	Counts
Participants	OG000112 OG001112

Title

Denominators

Categories

Title	Measurements
	OG00064.3 OG00154.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	To show non-inferiority for the primary endpoint, 100 subjects per group provides 80% power to show that the 95% CI for the difference of proportions between treatments is within the 20% margin under the assumption of equality of proportions. It is also sufficient to show superiority under the assumption that the first proportion is greater than the second by at least 20%. With a predicted withdrawal rate of 15%, 236 subjects were needed based on a treatment ratio of 1:1 for the two treatments.	Test for Difference in Proportions		0.0411		Odds Ratio (OR)	1.86				95	1.03	3.37					Non-Inferiority or Equivalence

Secondary

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

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

Posted

Number

percentage of participants

week 20

ID	Title	Description
OG000	FPG 70-90 mg/dL	Aggressive FPG (fasting plasma glucose) titration target range group
OG001	FPG 80-110 mg/dL	Conventional FPG (fasting plasma glucose) titration target range group

Units	Counts
Participants	OG000

Secondary

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

The intent-to-treat (ITT), LOCF (last observation carried forward) population. One Subject in 70-90 group, however, had a missing baseline value, therefore, no change from baseline could be calculated.

Posted

Least Squares Mean

Standard Error

percentage point change

week -2, week 20

ID	Title	Description
OG000	FPG 70-90 mg/dL	Aggressive FPG (fasting plasma glucose) titration target range group
OG001	FPG 80-110 mg/dL	Conventional FPG (fasting plasma glucose) titration target range group

Units	Counts
Participants	OG000

Secondary

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.

The safety population consists of all subjects exposed to study drug.

Posted

Number

number of events

weeks 0-20

ID	Title	Description
OG000	FPG 70-90 mg/dL	Aggressive FPG (fasting plasma glucose) titration target range group
OG001	FPG 80-110 mg/dL	Conventional FPG (fasting plasma glucose) titration target range group

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FPG 70-90 mg/dL	Aggressive FPG (fasting plasma glucose) titration target range group			5	121	45	121
EG001	FPG 80-110 mg/dL	Conventional FPG (fasting plasma glucose) titration target range group			4	122	30	122

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events1 affected121 at risk EG0010 events0 affected122 at risk
Appendicitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Pneumonia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected121 at risk EG0011 events1 affected122 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected121 at risk EG0010 events0 affected122 at risk
Metastases To Bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0010 events0 affected122 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0013 events3 affected122 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected121 at risk EG0013 events3 affected122 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected121 at risk EG0011 events1 affected122 at risk
Bronchitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected121 at risk EG0011 events1 affected122 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected121 at risk EG0013 events3 affected122 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected121 at risk EG0014 events4 affected122 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected121 at risk EG0010 events0 affected122 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0007 events7 affected121 at risk EG0012 events2 affected122 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected121 at risk EG0014 events4 affected122 at risk
Dizziness	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected121 at risk EG0012 events2 affected122 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected121 at risk EG0012 events2 affected122 at risk
Anxiety	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected121 at risk EG0013 events3 affected122 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0005 events5 affected121 at risk EG0012 events2 affected122 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D000069057	Insulin Detemir

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

The primary hypothesis was that there would be no difference in efficacy as measured by the proportion of subjects reaching HbA1c level < 7% between the two FPG titration arms (70-90 mg/dL and 80-110 mg/dL, respectively) with a non-inferiority margin of 20%. If non-inferiority of the 70-90mg/dL arm was established, superiority was to be tested using a Logistic regression model with baseline HbA1c as a covariate. Superiority was to be concluded if the odds ratio was significantly greater than 1.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases