Table 2. On-treatment analysis of the longitudinal effect of INI vs. Placebo over 24 weeks anthropometric measurements, body composition, and food intake.

Linear mixed-effect models testing for differences between the effect of INI and Placebo over 24 weeks of treatment. Variance was estimated using restricted maximum likelihood technique and results are displayed as estimate (standard error of estimate). P-values are derived from the interaction between covariates, gender, diagnosis of diabetes, and BMI, and treatment effect. INI (intranasal insulin), SE (standard error), Body Mass Index (BMI).

Outcomes	INI vs. Placebo			Interaction effect by
				Gender	Diagnosis of Diabetes	BMI
	n	Estimate (SE)	p-value	p-value	p-value	p-value
Anthropometric measurements
Weight, kg	89	−5.0 (3.5)	0.16	0.28	0.50	-
BMI, kg/m2	89	−1.5 (1.2)	0.22	0.44	0.91	-
Waist circumference, cm	89	−2.3 (3.2)	0.48	0.29	0.67	-
Body composition
Basal metabolic rate, kcal	60	−113.6 (71.4)	0.12	0.67	0.46	0.45
Fat mass, kg	60	−2.2 (2.8)	0.44	0.96	0.43	0.23
Lean mass, kg	60	−4.7 (3.2)	0.14	0.73	0.63	0.89
Total body water, %	60	−0.8 (1.8)	0.65	0.72	0.79	0.48
Food intake
Energy intake, kcal	76	−150.9 (122.7)	0.22	0.25	0.31	0.49
Calories from carbohydrates, kcal	76	−94.1 (69.6)	0.18	0.75	0.40	0.84
Calories from proteins, kcal	76	−37.9 (25.9)	0.15	0.14	0.10	0.38
Calories from fat, kcal	76	−15.2 (46.1)	0.74	0.26	0.66	0.17