Comparing Efficacy and Safety of Insulin Detemir Plus Ins... | NCT01486966

NCT01486966

ID	Type	Description	Link
U1111-1123-7088	Other Identifier	WHO

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
Insulin detemir / IAsp	Experimental		Drug: insulin detemir Drug: insulin aspart Drug: metformin
insulin NPH	Active Comparator		Drug: insulin NPH Drug: human soluble insulin Drug: metformin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin detemir	Drug	Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4	Insulin detemir / IAsp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment	Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.	Week 0, week 2

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment	The FPG referred to pre-breakfast plasma glucose.	Week 0, week 2
Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment

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		Beijing	Beijing Municipality	100034	China
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	Guo X, Li Q, Shi Y, Bu R, Liu J, Qu S, Gao Y. Efficacy and safety of insulin detemir plus insulin aspart versus NPH insulin plus human soluble insulin with or without metformin in Chinese type 2 diabetes. Chinese J Diabetes 2014; 22 (1)

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	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

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	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
BG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00029 BG00129 BG00258

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00057.6± 10.2 BG00155.8± 9.8 BG00256.7± 9.9

Sex: Female, Male

Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG00115 BG002

Race (NIH/OMB)

Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010

Height

Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000164.2± 8.5 BG001164.2± 8.4

Weight

Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00070.9± 13.1 BG00166.5± 9.0

Body mass index (BMI)

Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00026.09± 3.13 BG00124.63± 2.67

Pre-trial treatment of oral antidiabetic drug

Number

participants

Title

Denominators

Categories

Acarbose

Title	Measurements
	BG0009 BG00110 BG002

Pre-trial insulin treatment

Number

participants

Title

Denominators

Categories

basal insulin (once daily)

Title	Measurements
	BG0006 BG0017 BG002

Glycosylated haemoglobin A1c (HbA1c)

Recorded at Visit 1 (screening visit), which was 1 week but no earlier than 2 weeks prior to randomisation.

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.76± 0.73 BG001

Type 2 diabetes

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG00029 BG00129 BG002

Duration of diagnosed diabetes

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00010.23± 5.08 BG00111.97± 7.14 BG002

Diabetes complications

Number

participants

Title

Denominators

Categories

Diabetic complications

Title	Measurements
	BG00013 BG00115 BG002

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

Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment

Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 0, week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Units	Counts
Participants	OG00029 OG00127

Title

Denominators

Categories

Title	Measurements
	OG000-2.84± 0.27 OG001-2.80± 0.28

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment

The FPG referred to pre-breakfast plasma glucose.

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 0, week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Units	Counts
Participants

Secondary

Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment

The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 0, week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Units

Secondary

Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment

The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.

Posted

Least Squares Mean

Standard Error

mmol/L

Week 0, week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Secondary

Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.

Posted

Number

percentage (%) of subjects

Week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.

Posted

Number

percentage (%) of subjects

Week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Units	Counts
Participants

Secondary

Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment

FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L.

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.

Posted

Number

percentage (%) of subjects

Week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Units	Counts
Participants

Secondary

Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment

FPG target was < 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.

Posted

Number

percentage (%) of subjects

Week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Units	Counts

Secondary

Change From Baseline in Fructosamine After Two Weeks of Treatment

Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.

Posted

Least Squares Mean

Standard Error

Umol/L

Week 0, week 2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

Units	Counts
Participants

Secondary

Incidence of Hypoglycaemic Episodes

All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.

Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) < 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value < 3.1 mmol/l (56 mg/dl).

A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal.

Safety analysis set included all subjects receiving at least one dose of the trial products.

Posted

Number

events

Weeks 0-2

ID	Title	Description
OG000	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
OG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.

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	Insulin Detemir + Insulin Aspart ± Metformin	Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.			0	29	0	29
EG001	Insulin NPH + Human Soluble Insulin ± Metformin	Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.			0	29	2	29

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
upper restiratory tract infection	Infections and infestations	MedDRA 15.0	Systematic Assessment	In the clinical trial report, the overall conclusion "No adverse event (AE) with incidence ≥ 5 % was reported in this trial" was based on treatment emergent AEs experienced by at least 5% of all subjects. The incidence in the total subjects was 3.4%.	EG0000 events0 affected29 at risk EG0012 events2 affected29 at risk

The size of population analysed in study was smaller than that planned in the protocol. Therefore, the superiority of experimental products to comparator could not be concluded with sufficient statistical power.

Certain Agreements

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D000069057	Insulin Detemir
D061267	Insulin Aspart
D007336	Insulin, Isophane
D008687	Metformin

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
D061266	Insulin, Short-Acting
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

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